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Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02663674
Recruitment Status : Terminated (Study terminated due to lack of feasibility of study design.)
First Posted : January 26, 2016
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Coccidioidomycosis
Interventions Drug: Fluconazole
Other: Placebo
Enrollment 72
Recruitment Details Recruitment occurred between Feb 2016 and May 2018 at community locations in Coccidioides-endemic areas. Participants were adults presenting with community acquired pneumonia (CAP) whose health care provider had made the decision to treat with an antibacterial.
Pre-assignment Details  
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Period Title: Overall Study
Started 33 39
Completed 26 29
Not Completed 7 10
Reason Not Completed
Lost to Follow-up             5             4
Withdrawal by Subject             1             4
Physician Decision             1             1
Other Event (Health Related)             0             1
Arm/Group Title Fluconazole Placebo Total
Hide Arm/Group Description Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. Total of all reporting groups
Overall Number of Baseline Participants 33 39 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  75.8%
33
  84.6%
58
  80.6%
>=65 years
8
  24.2%
6
  15.4%
14
  19.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 39 participants 72 participants
50.1  (16.1) 49.5  (12.6) 49.8  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
Female
18
  54.5%
18
  46.2%
36
  50.0%
Male
15
  45.5%
21
  53.8%
36
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
Hispanic or Latino
16
  48.5%
19
  48.7%
35
  48.6%
Not Hispanic or Latino
17
  51.5%
20
  51.3%
37
  51.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
American Indian or Alaska Native
1
   3.0%
0
   0.0%
1
   1.4%
Asian
0
   0.0%
2
   5.1%
2
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  12.1%
4
  10.3%
8
  11.1%
White
26
  78.8%
31
  79.5%
57
  79.2%
More than one race
1
   3.0%
1
   2.6%
2
   2.8%
Unknown or Not Reported
1
   3.0%
1
   2.6%
2
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 39 participants 72 participants
33 39 72
Positive for coccidioidomycosis pneumonia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
4
  12.1%
4
  10.3%
8
  11.1%
[1]
Measure Description:

Participant diagnosed with CAP and meets one of the following criteria:

  1. Pos. for any 2 of IDTP, IDCF, EIA-IgM, EIA-IgG, between D1-D29, not necessarily from the same assay or same time point.
  2. Neg. for anti-Cocci antibody by ID (or EIA-IgG) at D1; seroconvert to pos. for anti-Cocci antibody by ID (or EIA-IgG) between D1-D29
  3. Neg. or indet. for anti-Cocci antibody by CF on D1; demonstrates a titer of >= 2 by CF between D1-D29
  4. Pos. for anti-Cocci antibody by CF on D1 and demonstrates a rise of >= 2-fold dilution in CF titer compared to baseline between D1-D29.
1.Primary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected capsules.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
 100.0%
2.Secondary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
  66.7%
3.Secondary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Measure Type: Count of Participants
Unit of Measure: Participants
20
  74.1%
22
  62.9%
4.Secondary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes all participants who took at least one dose of study medication.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Measure Type: Count of Participants
Unit of Measure: Participants
20
  74.1%
22
  62.9%
5.Secondary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time Frame Visit 2 - Visit 4 (Day 20-46)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
2
 100.0%
6.Secondary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time Frame Visit 2 - Visit 4 (Day 20-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The population includes all participants who took at least one dose of study medication.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
28
  93.3%
7.Secondary Outcome
Title The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time Frame Visit 2 - Visit 4 (Day 20-46)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
28
  93.3%
8.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
3.04
(1 to 5)
3.49
(1 to 6)
Cough
0.85
(0 to 2)
0.86
(0 to 1)
Fatigue
0.74
(0 to 1)
0.74
(0 to 1)
Chest Pain
0.11
(0 to 0)
0.31
(0 to 0)
Dyspnea
0.48
(0 to 1)
0.60
(0 to 1)
Sputum Production
0.41
(0 to 1)
0.40
(0 to 1)
Night Sweats
0.26
(0 to 0)
0.37
(0 to 1)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.19
(0 to 0)
0.20
(0 to 0)
9.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.00
(1.00 to 5.00)
2.00
(1.00 to 6.00)
Cough
1
(0 to 2)
1
(0 to 1)
Fatigue
1
(0 to 1)
0
(0 to 1)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 1)
Sputum Production
0
(0 to 1)
0
(0 to 1)
Night Sweats
0
(0 to 0)
0
(0 to 1)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
10.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 26 31
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.58
(0 to 4)
1.97
(0 to 2)
Cough
0.73
(0 to 1)
0.48
(0 to 1)
Fatigue
0.62
(0 to 1)
0.42
(0 to 1)
Chest Pain
0.19
(0 to 0)
0.13
(0 to 0)
Dyspnea
0.46
(0 to 1)
0.42
(0 to 1)
Sputum Production
0.31
(0 to 0)
0.16
(0 to 0)
Night Sweats
0.15
(0 to 0)
0.19
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.12
(0 to 0)
0.16
(0 to 0)
11.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 26 31
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2
(0 to 4)
1
(0 to 2)
Cough
1
(0 to 1)
0
(0 to 1)
Fatigue
0
(0 to 1)
0
(0 to 1)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 1)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
12.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1.36
(0 to 2)
1.5
(0 to 2)
Cough
0.44
(0 to 1)
0.23
(0 to 0)
Fatigue
0.36
(0 to 1)
0.37
(0 to 0)
Chest Pain
0.08
(0 to 0)
0.17
(0 to 0)
Dyspnea
0.12
(0 to 0)
0.30
(0 to 0)
Sputum Production
0.24
(0 to 0)
0.13
(0 to 0)
Night Sweats
0.04
(0 to 0)
0.10
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.08
(0 to 0)
0.20
(0 to 0)
13.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1
(0 to 2)
1
(0 to 2)
Cough
0
(0 to 1)
0
(0 to 0)
Fatigue
0
(0 to 1)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
14.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 3
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.25
(1 to 3.5)
3.67
(0 to 10)
Cough
0.5
(0 to 1)
1
(0 to 2)
Fatigue
1.00
(0.5 to 1.5)
1.00
(0 to 3)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0.5
(0 to 1)
0.67
(0 to 2)
Sputum Production
0
(0 to 0)
0.33
(0 to 1)
Night Sweats
0.25
(0 to 0.5)
0.67
(0 to 2)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
15.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 3
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1
(1 to 3.5)
1
(0 to 10)
Cough
0
(0 to 1)
1
(0 to 2)
Fatigue
1
(0.5 to 1.5)
0
(0 to 3)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 2)
Sputum Production
0
(0 to 0)
0
(0 to 1)
Night Sweats
0
(0 to 0.5)
0
(0 to 2)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
16.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1.00
(0 to 2)
0.5
(0 to 1)
Cough
0.5
(0 to 1)
0
(0 to 0)
Fatigue
0.25
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0.25
(0 to 0.5)
0.5
(0 to 1)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
17.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0.5
(0 to 2)
0.5
(0 to 1)
Cough
0.5
(0 to 1)
0
(0 to 0)
Fatigue
0
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0.5)
0.5
(0 to 1)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
18.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0.75
(0 to 1.5)
0
(0 to 0)
Cough
0.25
(0 to 0.5)
0
(0 to 0)
Fatigue
0.25
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.25
(0 to 0.5)
0
(0 to 0)
19.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0
(0 to 1.5)
0
(0 to 0)
Cough
0
(0 to 0.5)
0
(0 to 0)
Fatigue
0
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0.5)
0
(0 to 0)
20.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
3.04
(1 to 5)
3.49
(1 to 6)
Cough
0.85
(0 to 2)
0.86
(0 to 1)
Fatigue
0.74
(0 to 1)
0.74
(0 to 1)
Chest Pain
0.11
(0 to 0)
0.31
(0 to 0)
Dyspnea
0.48
(0 to 1)
0.6
(0 to 1)
Sputum Production
0.41
(0 to 1)
0.40
(0 to 1)
Night Sweats
0.26
(0 to 0)
0.37
(0 to 1)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.19
(0 to 0)
0.20
(0 to 0)
21.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2
(1 to 5)
2
(1 to 6)
Cough
1
(0 to 2)
1
(0 to 1)
Fatigue
1
(0 to 1)
0
(0 to 1)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 1)
Sputum Production
0
(0 to 1)
0
(0 to 1)
Night Sweats
0
(0 to 0)
0
(0 to 1)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
22.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 26 31
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.58
(0 to 4)
1.97
(0 to 2)
Cough
0.73
(0 to 1)
0.48
(0 to 1)
Fatigue
0.62
(0 to 1)
0.42
(0 to 1)
Chest Pain
0.19
(0 to 0)
0.13
(0 to 0)
Dyspnea
0.46
(0 to 1)
0.42
(0 to 1)
Sputum Production
0.31
(0 to 0)
0.16
(0 to 0)
Night Sweats
0.15
(0 to 0)
0.19
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.12
(0 to 0)
0.16
(0 to 0)
23.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 26 31
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2
(0 to 4)
1
(0 to 2)
Cough
1
(0 to 1)
0
(0 to 1)
Fatigue
0
(0 to 1)
0
(0 to 1)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 1)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
24.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1.36
(0 to 2)
1.5
(0 to 2)
Cough
0.44
(0 to 1)
0.23
(0 to 0)
Fatigue
0.36
(0 to 1)
0.37
(0 to 0)
Chest Pain
0.08
(0 to 0)
0.17
(0 to 0)
Dyspnea
0.12
(0 to 0)
0.30
(0 to 0)
Sputum Production
0.24
(0 to 0)
0.13
(0 to 0)
Night Sweats
0.04
(0 to 0)
0.10
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.08
(0 to 0)
0.20
(0 to 0)
25.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1
(0 to 2)
1
(0 to 2)
Cough
0
(0 to 1)
0
(0 to 0)
Fatigue
0
(0 to 1)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
26.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.25
(1 to 3.5)
0.5
(0 to 1)
Cough
0.5
(0 to 1)
0.5
(0 to 1)
Fatigue
1.00
(0.5 to 1.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0.5
(0 to 1)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0.25
(0 to 0.5)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
27.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1
(1 to 3.5)
0.5
(0 to 1)
Cough
0
(0 to 1)
0.5
(0 to 1)
Fatigue
1
(0.5 to 1.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0.5)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
28.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1.00
(0 to 2)
0.5
(0 to 1)
Cough
0.5
(0 to 1)
0
(0 to 0)
Fatigue
0.25
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0.25
(0 to 0.5)
0.5
(0 to 1)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
29.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0.5
(0 to 2)
0.5
(0 to 1)
Cough
0.5
(0 to 1)
0
(0 to 0)
Fatigue
0
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0.5)
0.5
(0 to 1)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
30.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0.75
(0 to 1.5)
0
(0 to 0)
Cough
0.25
(0 to 0.5)
0
(0 to 0)
Fatigue
0.25
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.25
(0 to 0.5)
0
(0 to 0)
31.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0
(0 to 1.5)
0
(0 to 0)
Cough
0
(0 to 0.5)
0
(0 to 0)
Fatigue
0
(0 to 0.5)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0.5)
0
(0 to 0)
32.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 29
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.64
(1 to 4)
3.72
(1 to 6)
Cough
0.80
(0 to 1)
0.97
(0 to 1)
Fatigue
0.72
(0 to 1)
0.76
(0 to 1)
Chest Pain
0.08
(0 to 0)
0.34
(0 to 0)
Dyspnea
0.40
(0 to 1)
0.66
(0 to 1)
Sputum Production
0.32
(0 to 1)
0.45
(0 to 1)
Night Sweats
0.16
(0 to 0)
0.38
(0 to 1)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.16
(0 to 0)
0.17
(0 to 0)
33.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2
(1 to 4)
3
(1 to 6)
Cough
1
(0 to 1)
1
(0 to 1)
Fatigue
1
(0 to 1)
0
(0 to 1)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 1)
Sputum Production
0
(0 to 1)
0
(0 to 1)
Night Sweats
0
(0 to 0)
0
(0 to 1)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
34.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 24 25
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2.42
(0 to 3.5)
1.96
(0 to 2)
Cough
0.71
(0 to 1)
0.48
(0 to 1)
Fatigue
0.63
(0 to 1)
0.44
(0 to 1)
Chest Pain
0.17
(0 to 0)
0.12
(0 to 0)
Dyspnea
0.42
(0 to 1)
0.44
(0 to 1)
Sputum Production
0.33
(0 to .5)
0.16
(0 to 0)
Night Sweats
0.08
(0 to 0)
0.20
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.08
(0 to 0)
0.12
(0 to 0)
35.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 24 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
2
(0 to 3.5)
1
(0 to 2)
Cough
1
(0 to 1)
0
(0 to 1)
Fatigue
0
(0 to 1)
0
(0 to 1)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 1)
0
(0 to 1)
Sputum Production
0
(0 to 0.5)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
36.Secondary Outcome
Title The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 23 24
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
1.09
(0 to 2)
1.25
(0 to 2)
Cough
0.35
(0 to 1)
0.21
(0 to 0)
Fatigue
0.35
(0 to 1)
0.38
(0 to 0)
Chest Pain
0.04
(0 to 0)
0.13
(0 to 0)
Dyspnea
0.09
(0 to 0)
0.21
(0 to 0)
Sputum Production
0.13
(0 to 0)
0.08
(0 to 0)
Night Sweats
0.04
(0 to 0)
0.08
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0.09
(0 to 0)
0.17
(0 to 0)
37.Secondary Outcome
Title The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
Hide Description The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 23 24
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Total FLEET CAP Score
0
(0 to 2)
0.5
(0 to 2)
Cough
0
(0 to 1)
0
(0 to 0)
Fatigue
0
(0 to 1)
0
(0 to 0)
Chest Pain
0
(0 to 0)
0
(0 to 0)
Dyspnea
0
(0 to 0)
0
(0 to 0)
Sputum Production
0
(0 to 0)
0
(0 to 0)
Night Sweats
0
(0 to 0)
0
(0 to 0)
Fever
0
(0 to 0)
0
(0 to 0)
Hypoxia
0
(0 to 0)
0
(0 to 0)
38.Secondary Outcome
Title Number of the Days of School or Work Missed Due to Illness in the ITT Population
Hide Description Number of the days of school or work missed due to illness by participant self-report
Time Frame Visit 1 (Day 1) through Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: days
0  (0) 1.5  (5.2)
39.Secondary Outcome
Title Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population
Hide Description Number of the days of school or work missed due to illness by participant self-report
Time Frame Visit 1 (Day 1) through Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 2 0
Mean (Standard Deviation)
Unit of Measure: days
0  (0)
40.Secondary Outcome
Title Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population
Hide Description Number of the days of school or work missed due to illness by participant self-report
Time Frame Visit 1 (Day 1) through Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days
0  (0) 0.6  (1.8)
41.Secondary Outcome
Title Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population
Hide Description Number of the days of school or work missed due to illness by participant self-report
Time Frame Visit 1 (Day 1) through Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 2 0
Mean (Standard Deviation)
Unit of Measure: days
0  (0)
42.Secondary Outcome
Title Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population
Hide Description Number of the days of school or work missed due to illness by participant self-report
Time Frame Visit 1 (Day 1) through Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: days
0  (0) 1.5  (5.2)
43.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 27 35
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
1
   3.7%
3
   8.6%
Rarely
1
   3.7%
4
  11.4%
Sometimes
7
  25.9%
8
  22.9%
Usually
3
  11.1%
7
  20.0%
Always
15
  55.6%
13
  37.1%
Trouble doing family activities I want to do Never
0
   0.0%
3
   8.6%
Rarely
3
  11.1%
4
  11.4%
Sometimes
4
  14.8%
7
  20.0%
Usually
5
  18.5%
6
  17.1%
Always
15
  55.6%
15
  42.9%
Trouble doing usual work (incl work at home) Never
0
   0.0%
3
   8.6%
Rarely
5
  18.5%
4
  11.4%
Sometimes
7
  25.9%
9
  25.7%
Usually
4
  14.8%
6
  17.1%
Always
11
  40.7%
13
  37.1%
Trouble doing activities with friends I want to do Never
1
   3.7%
4
  11.4%
Rarely
3
  11.1%
2
   5.7%
Sometimes
5
  18.5%
10
  28.6%
Usually
4
  14.8%
7
  20.0%
Always
14
  51.9%
12
  34.3%
44.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 26 31
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
3
  11.5%
1
   3.2%
Sometimes
6
  23.1%
8
  25.8%
Usually
4
  15.4%
13
  41.9%
Always
13
  50.0%
9
  29.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
2
   7.7%
1
   3.2%
Sometimes
6
  23.1%
11
  35.5%
Usually
4
  15.4%
10
  32.3%
Always
14
  53.8%
9
  29.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
4
  15.4%
3
   9.7%
Sometimes
5
  19.2%
10
  32.3%
Usually
4
  15.4%
10
  32.3%
Always
13
  50.0%
8
  25.8%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
2
   7.7%
3
   9.7%
Sometimes
6
  23.1%
7
  22.6%
Usually
5
  19.2%
10
  32.3%
Always
13
  50.0%
11
  35.5%
45.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 30
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
1
   4.0%
4
  13.3%
Sometimes
6
  24.0%
6
  20.0%
Usually
4
  16.0%
8
  26.7%
Always
14
  56.0%
12
  40.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
2
   8.0%
4
  13.3%
Sometimes
5
  20.0%
5
  16.7%
Usually
2
   8.0%
6
  20.0%
Always
16
  64.0%
15
  50.0%
Trouble doing usual work (incl work at home) Never
1
   4.0%
0
   0.0%
Rarely
1
   4.0%
4
  13.3%
Sometimes
5
  20.0%
4
  13.3%
Usually
4
  16.0%
11
  36.7%
Always
14
  56.0%
11
  36.7%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
2
   8.0%
5
  16.7%
Sometimes
5
  20.0%
5
  16.7%
Usually
4
  16.0%
4
  13.3%
Always
14
  56.0%
16
  53.3%
46.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 6 (Day 83-97)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing usual work (incl work at home) Never
1
  25.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
47.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 7 (Day 173-187)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population includes all randomized participants.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
48.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
1
  50.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
  50.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
1
  50.0%
Always
3
  75.0%
1
  50.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
1
  50.0%
Usually
1
  25.0%
0
   0.0%
Always
2
  50.0%
1
  50.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
1
  50.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
  50.0%
49.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
50.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
2
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
2
 100.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
1
  50.0%
Always
3
  75.0%
1
  50.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
2
 100.0%
51.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 6 (Day 83-97)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing usual work (incl work at home) Never
1
  25.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
52.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 7 (Day 173-187)
Hide Outcome Measure Data
Hide Analysis Population Description
The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
53.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
1
  33.3%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
1
  33.3%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
  33.3%
Trouble doing family activities I want to do Never
0
   0.0%
1
  33.3%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
1
  33.3%
Always
3
  75.0%
1
  33.3%
Trouble doing usual work (incl work at home) Never
0
   0.0%
1
  33.3%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
1
  33.3%
Usually
1
  25.0%
0
   0.0%
Always
2
  50.0%
1
  33.3%
Trouble doing activities with friends I want to do Never
0
   0.0%
1
  33.3%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
1
  33.3%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
  33.3%
54.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
1
  25.0%
1
  50.0%
Always
2
  50.0%
1
  50.0%
55.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 4 (Day 42-46)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
2
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
2
 100.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
1
  50.0%
Always
3
  75.0%
1
  50.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
2
 100.0%
56.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 6 (Day 83-97)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing usual work (incl work at home) Never
1
  25.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
57.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 7 (Day 173-187)
Hide Outcome Measure Data
Hide Analysis Population Description
Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing family activities I want to do Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
1
  25.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing usual work (incl work at home) Never
0
   0.0%
0
   0.0%
Rarely
0
   0.0%
0
   0.0%
Sometimes
1
  25.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
0
   0.0%
Rarely
1
  25.0%
0
   0.0%
Sometimes
0
   0.0%
0
   0.0%
Usually
0
   0.0%
0
   0.0%
Always
3
  75.0%
1
 100.0%
58.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 2 (Day 20-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 25 29
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
1
   3.4%
Rarely
1
   4.0%
4
  13.8%
Sometimes
7
  28.0%
8
  27.6%
Usually
3
  12.0%
7
  24.1%
Always
14
  56.0%
9
  31.0%
Trouble doing family activities I want to do Never
0
   0.0%
1
   3.4%
Rarely
2
   8.0%
4
  13.8%
Sometimes
4
  16.0%
7
  24.1%
Usually
5
  20.0%
6
  20.7%
Always
14
  56.0%
11
  37.9%
Trouble doing usual work (incl work at home) Never
0
   0.0%
1
   3.4%
Rarely
5
  20.0%
4
  13.8%
Sometimes
5
  20.0%
9
  31.0%
Usually
4
  16.0%
6
  20.7%
Always
11
  44.0%
9
  31.0%
Trouble doing activities with friends I want to do Never
0
   0.0%
2
   6.9%
Rarely
3
  12.0%
2
   6.9%
Sometimes
5
  20.0%
10
  34.5%
Usually
4
  16.0%
7
  24.1%
Always
13
  52.0%
8
  27.6%
59.Secondary Outcome
Title Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
Hide Description The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time Frame Visit 3 (Day 27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
Arm/Group Title Fluconazole Placebo
Hide Arm/Group Description:
Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days.
Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days.
Overall Number of Participants Analyzed 24 25
Measure Type: Count of Participants
Unit of Measure: Participants
Trouble doing regular leisure activities w others Never
0
   0.0%
0
   0.0%
Rarely
3
  12.5%
1
   4.0%
Sometimes
5
  20.8%
6
  24.0%
Usually
4
  16.7%
13
  52.0%