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CleanUP IPF for the Pulmonary Trials Cooperative (CleanUp-IPF)

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: NCT02759120
Recruitment Status : Terminated (Terminated for futility after review of first planned interim analysis.)
First Posted : May 3, 2016
Results First Posted : March 3, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Duke Clinical Research Institute
University of Chicago
University of Washington
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline
Other: No Intervention: Standard of Care
Enrollment 513
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Period Title: Overall Study
Started 254 259
Completed 169 180
Not Completed 85 79
Reason Not Completed
Death             34             36
Lost to Follow-up             4             7
Physician Decision             3             0
Withdrawal by Subject             28             15
Moved out of area             3             4
Lung transplant             3             5
Other reason not completed             10             12
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care Total
Hide Arm/Group Description

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Total of all reporting groups
Overall Number of Baseline Participants 254 259 513
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 259 participants 513 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  18.9%
44
  17.0%
92
  17.9%
>=65 years
206
  81.1%
215
  83.0%
421
  82.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 259 participants 513 participants
Female
60
  23.6%
51
  19.7%
111
  21.6%
Male
194
  76.4%
208
  80.3%
402
  78.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 259 participants 513 participants
Hispanic or Latino
13
   5.1%
10
   3.9%
23
   4.5%
Not Hispanic or Latino
241
  94.9%
249
  96.1%
490
  95.5%
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 254 participants 259 participants 513 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
9
   3.5%
5
   1.9%
14
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   2.8%
4
   1.5%
11
   2.1%
White
231
  90.9%
244
  94.2%
475
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   2.8%
5
   1.9%
12
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 254 participants 259 participants 513 participants
254 259 513
Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Coronary artery disease Number Analyzed 254 participants 259 participants 513 participants
69
  27.2%
79
  30.5%
148
  28.8%
Myocardial infarct Number Analyzed 251 participants 259 participants 510 participants
20
   8.0%
32
  12.4%
52
  10.2%
Valvular heart disease Number Analyzed 252 participants 256 participants 508 participants
7
   2.8%
13
   5.1%
20
   3.9%
Congestive heart failure Number Analyzed 254 participants 258 participants 512 participants
8
   3.1%
12
   4.7%
20
   3.9%
Stroke Number Analyzed 254 participants 258 participants 512 participants
9
   3.5%
10
   3.9%
19
   3.7%
Osteoarthritis Number Analyzed 251 participants 256 participants 507 participants
66
  26.3%
73
  28.5%
139
  27.4%
Osteoporosis Number Analyzed 252 participants 258 participants 510 participants
19
   7.5%
11
   4.3%
30
   5.9%
Hypertension Number Analyzed 252 participants 258 participants 510 participants
127
  50.4%
129
  50.0%
256
  50.2%
High cholesterol Number Analyzed 252 participants 257 participants 509 participants
144
  57.1%
154
  59.9%
298
  58.5%
Stomach ulcers Number Analyzed 253 participants 257 participants 510 participants
12
   4.7%
16
   6.2%
28
   5.5%
Hay fever Number Analyzed 250 participants 253 participants 503 participants
51
  20.4%
46
  18.2%
97
  19.3%
Atrial fibrillation Number Analyzed 252 participants 258 participants 510 participants
21
   8.3%
31
  12.0%
52
  10.2%
Intermittent claudication Number Analyzed 248 participants 258 participants 506 participants
2
   0.8%
7
   2.7%
9
   1.8%
Peripheral vascular disease Number Analyzed 247 participants 259 participants 506 participants
9
   3.6%
11
   4.2%
20
   4.0%
Cerebrovascular disease Number Analyzed 252 participants 259 participants 511 participants
3
   1.2%
4
   1.5%
7
   1.4%
Dementia Number Analyzed 254 participants 259 participants 513 participants
0
   0.0%
3
   1.2%
3
   0.6%
Chronic pulmonary disease Number Analyzed 254 participants 259 participants 513 participants
151
  59.4%
163
  62.9%
314
  61.2%
Connective tissue disease Number Analyzed 249 participants 258 participants 507 participants
2
   0.8%
1
   0.4%
3
   0.6%
Ulcer disease Number Analyzed 253 participants 257 participants 510 participants
4
   1.6%
3
   1.2%
7
   1.4%
Mild liver disease Number Analyzed 253 participants 258 participants 511 participants
7
   2.8%
5
   1.9%
12
   2.3%
Diabetes Number Analyzed 254 participants 259 participants 513 participants
49
  19.3%
39
  15.1%
88
  17.2%
Hemiplegia Number Analyzed 252 participants 258 participants 510 participants
0
   0.0%
1
   0.4%
1
   0.2%
Moderate or sever renal disease Number Analyzed 253 participants 259 participants 512 participants
9
   3.6%
8
   3.1%
17
   3.3%
Diabetes with end organ damage Number Analyzed 253 participants 259 participants 512 participants
0
   0.0%
1
   0.4%
1
   0.2%
Any tumor Number Analyzed 254 participants 259 participants 513 participants
21
   8.3%
16
   6.2%
37
   7.2%
Leukemia Number Analyzed 254 participants 259 participants 513 participants
0
   0.0%
1
   0.4%
1
   0.2%
Moderate or severe disease Number Analyzed 253 participants 258 participants 511 participants
4
   1.6%
3
   1.2%
7
   1.4%
Metastatic solid tumor Number Analyzed 254 participants 259 participants 513 participants
1
   0.4%
0
   0.0%
1
   0.2%
AIDS Number Analyzed 254 participants 259 participants 513 participants
0
   0.0%
0
   0.0%
0
   0.0%
Lung cancer Number Analyzed 254 participants 259 participants 513 participants
3
   1.2%
4
   1.5%
7
   1.4%
Other cancer (excluding basal cell carcinoma) Number Analyzed 254 participants 259 participants 513 participants
39
  15.4%
37
  14.3%
76
  14.8%
Gastroesophageal reflux disease (GERD) Number Analyzed 251 participants 256 participants 507 participants
156
  62.2%
149
  58.2%
305
  60.2%
Asthma Number Analyzed 253 participants 257 participants 510 participants
14
   5.5%
12
   4.7%
26
   5.1%
Evidence of pulmonary hypertension Number Analyzed 253 participants 254 participants 507 participants
19
   7.5%
21
   8.3%
40
   7.9%
Emphysema or chronic bronchitis Number Analyzed 254 participants 259 participants 513 participants
25
   9.8%
28
  10.8%
53
  10.3%
Lymphoma Number Analyzed 253 participants 259 participants 512 participants
1
   0.4%
2
   0.8%
3
   0.6%
[1]
Measure Analysis Population Description: Data could not be located.
Physical Exam   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Clubbing Number Analyzed 253 participants 256 participants 509 participants
41
  16.2%
51
  19.9%
92
  18.1%
Bibasilar, inspiratory crackles Number Analyzed 252 participants 259 participants 511 participants
238
  94.4%
240
  92.7%
478
  93.5%
Jugular venous distension Number Analyzed 254 participants 259 participants 513 participants
4
   1.6%
4
   1.5%
8
   1.6%
Increased P2 Number Analyzed 240 participants 251 participants 491 participants
7
   2.9%
8
   3.2%
15
   3.1%
Peripheral edema Number Analyzed 254 participants 259 participants 513 participants
16
   6.3%
20
   7.7%
36
   7.0%
Other significant finding Number Analyzed 254 participants 259 participants 513 participants
13
   5.1%
10
   3.9%
23
   4.5%
[1]
Measure Analysis Population Description: Data could not be located.
Standard of Care medications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Pirfenidone Number Analyzed 253 participants 259 participants 512 participants
158
  62.5%
160
  61.8%
318
  62.1%
Nintedanib Number Analyzed 253 participants 259 participants 512 participants
101
  39.9%
97
  37.5%
198
  38.7%
[1]
Measure Analysis Population Description: Data could not be located.
Prior medications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Proton pump inhibitors (PPI) Number Analyzed 253 participants 259 participants 512 participants
158
  62.5%
158
  61.0%
316
  61.7%
H2 blockers (H2 receptor antagonists) Number Analyzed 253 participants 259 participants 512 participants
49
  19.4%
53
  20.5%
102
  19.9%
Chronic prednisone (> 1 month) Number Analyzed 253 participants 259 participants 512 participants
43
  17.0%
53
  20.5%
96
  18.8%
Azathioprine Number Analyzed 253 participants 259 participants 512 participants
1
   0.4%
3
   1.2%
4
   0.8%
N-acetylcysteine (NAC) Number Analyzed 253 participants 259 participants 512 participants
14
   5.5%
13
   5.0%
27
   5.3%
Co-trimoxazole Number Analyzed 253 participants 259 participants 512 participants
43
  17.0%
38
  14.7%
81
  15.8%
Doxycycline Number Analyzed 253 participants 259 participants 512 participants
54
  21.3%
41
  15.8%
95
  18.6%
[1]
Measure Analysis Population Description: Data could not be located.
Forced Expiratory Volume in 1 second (FEV1)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 247 participants 255 participants 502 participants
2.20  (0.621) 2.23  (0.624) 2.22  (0.622)
[1]
Measure Analysis Population Description: Data could not be located.
Forced expiratory volume in 1 second (FEV1) percent predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 237 participants 254 participants 491 participants
78.79  (19.656) 77.01  (18.195) 77.87  (18.916)
[1]
Measure Analysis Population Description: Data could not be located.
Forced expiratory volume (FEV1)/Forced vital capacity (FVC) percentage   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 242 participants 258 participants 500 participants
73.68  (2.138) 73.46  (2.098) 73.57  (2.118)
[1]
Measure Analysis Population Description: Data could not be located.
Forced vital capacity (FVC)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 247 participants 255 participants 502 participants
2.71  (0.798) 2.78  (0.848) 2.75  (0.824)
[1]
Measure Analysis Population Description: Data could not be located.
Forced vital capacity (FVC) percent predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 237 participants 254 participants 491 participants
71.36  (18.071) 70.20  (17.683) 70.76  (17.863)
[1]
Measure Analysis Population Description: Data could not be located.
Diffusing capacity of the lung for carbon monoxide (DCLO)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/mmHg
Number Analyzed 240 participants 252 participants 492 participants
11.50  (4.630) 11.74  (4.414) 11.62  (4.518)
[1]
Measure Analysis Population Description: Data could not be located.
Diffusing capacity of the lung for carbon monoxide (DLCO) corrected   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/mmHg
Number Analyzed 185 participants 192 participants 377 participants
11.42  (4.323) 192  (4.466) 11.59  (4.393)
[1]
Measure Analysis Population Description: Data could not be located.
Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (actual)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 233 participants 251 participants 484 participants
40.48  (16.738) 39.78  (13.832) 40.11  (15.288)
[1]
Measure Analysis Population Description: Data could not be located.
Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (corrected)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 179 participants 191 participants 370 participants
40.20  (15.040) 40.00  (13.988) 40.10  (14.487)
[1]
Measure Analysis Population Description: Data could not be located.
Diffusing capacity of the lung for carbon monoxide (DLCO) percent predicted (best available)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 233 participants 251 participants 484 participants
40.68  (16.939) 40.11  (13.814) 40.38  (15.384)
[1]
Measure Analysis Population Description: Data could not be located.
GAP stage   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
I Number Analyzed 233 participants 251 participants 484 participants
60 54 144
II Number Analyzed 233 participants 251 participants 484 participants
124 133 257
III Number Analyzed 233 participants 251 participants 484 participants
49 64 113
[1]
Measure Description:

The GAP stage assessment system is a clinical prediction tool that estimates prognosis in patients with idiopathic pulmonary fibrosis. The GAP model includes four baseline variables that were found to be predictive of outcome, as identified by logistic regression. These factors are: gender (G), age (A) and two lung physiology variables (P) (forced vital capacity and diffusing capacity of the lung for carbon monoxide). A higher stage indicates a higher rate of mortality.

One year mortality rates by stage:

Stage I = 6% Stage II=16% Stage III = 39%

[2]
Measure Analysis Population Description: Data could not be located.
University of California San Diego (UCSD) shortness of breath questionnaire total score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 251 participants 257 participants 508 participants
32.62  (24.246) 32.91  (32.91) 32.77  (32.77)
[1]
Measure Description:

University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ) total score (0 - 120 range). A lower score indicates a better health score.

The UCSD SOBQ is a 24-item self-administered questionnaire that assesses dyspnea associated with activities of daily living.

[2]
Measure Analysis Population Description: Data could not be located.
EuroQoL index score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 250 participants 255 participants 505 participants
0.80  (0.191) 0.80  (0.173) 0.80  (0.182)
[1]
Measure Description:

EuroQoL score (0 - 1 range). A higher score indicates a better health score.

This self-administered instrument includes five health state items (e.g. mobility, self-care).

[2]
Measure Analysis Population Description: Data could not be located.
EuroQoL thermometer response   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 218 participants 212 participants 430 participants
68.90  (22.286) 69.78  (20.044) 69.33  (21.190)
[1]
Measure Description:

EuroQoL visual analog scale (0 - 100 range). A higher score indicates a better health score.

Includes a 0-100 "thermometer" rating of current state of health from 0 as worst imaginable to 100 as best.

[2]
Measure Analysis Population Description: Data could not be located.
ICEpop CAPability Measure for Older People (ICECAP-O) Score summary score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 253 participants 258 participants 511 participants
0.35  (0.217) 0.36  (0.209) 0.36  (0.213)
[1]
Measure Description: ICEpop CAPability Measure for Older People (ICECAP-O) Score (0 - 1 range). A lower score indicates a better health score. The ICECAP-O is a measure of capability in older people for use in economic evaluation.
[2]
Measure Analysis Population Description: Data could not be located.
SF12 mental component summary (MCS) score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 252 participants 258 participants 510 participants
0.35  (0.217) 0.36  (0.209) 0.36  (0.213)
[1]
Measure Description:

Short Form-12 mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.

The Short Form 12 MSC score assess mental health and well-being.

[2]
Measure Analysis Population Description: Data could not be located.
SF12 physical component summary (PCS) score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 251 participants 258 participants 509 participants
41.46  (8.776) 40.23  (9.171) 40.83  (8.991)
[1]
Measure Description:

Short form-12 physical components summary (PSC) score (0 - 100 range). A higher score indicates a better health score.

The Short form-12 PSC score assesses limitations in physical activity because of health problems.

[2]
Measure Analysis Population Description: Data could not be located.
SF6D score (economic evaluation)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 249 participants 258 participants 507 participants
0.72  (0.115) 0.72  (0.114) 0.72  (0.115)
[1]
Measure Description:

Short form-12 6D health survey score (0.29 - 1.00 range). A higher score indicates a better health score.

The Short form-12 6D health survey provides an economical evaluation.

[2]
Measure Analysis Population Description: Data could not be located.
Fatigue Severity Scale score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 252 participants 253 participants 505 participants
3.81  (1.554) 3.98  (1.708) 3.90  (1.633)
[1]
Measure Description: Fatigue Severity Score (1 - 7 range). A lower score indicates a better health score. The fatigue severity questionnaire measures how fatigue impacts one's ability to function in the last week.
[2]
Measure Analysis Population Description: Data could not be located.
Leicester cough questionnaire total score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 249 participants 257 participants 506 participants
16.71  (3.681) 17.19  (3.589) 16.95  (3.638)
[1]
Measure Description:

Leicester cough questionnaire total score (3 - 21 range). A higher score indicates a better health score.

The Leicester cough questionnaire assesses symptoms of cough frequency and severity.

[2]
Measure Analysis Population Description: Data could not be located.
1.Primary Outcome
Title Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Count of Participants
Unit of Measure: Participants
52
  20.5%
56
  21.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.71 to 1.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Death From Any Cause
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Count of Participants
Unit of Measure: Participants
37
  14.6%
37
  14.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.70 to 1.78
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With First Non-elective, Respiratory Hospitalization
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Count of Participants
Unit of Measure: Participants
36
  14.2%
31
  12.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.82 to 2.17
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With First Non-elective, All-cause Hospitalization
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Count of Participants
Unit of Measure: Participants
54
  21.3%
47
  18.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.91 to 2.01
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Total Number of Non-elective Respiratory Hospitalizations
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Number
Unit of Measure: hospitalizations
55 43
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.78 to 1.89
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Total Number of Non-elective All-cause Hospitalizations
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Number
Unit of Measure: hospitalizations
72 52
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.90 to 1.83
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change in Forced Vital Capacity (FVC)
Hide Description [Not Specified]
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: percent change
-2.99
(-4.23 to -1.75)
-4.13
(-5.28 to -2.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
-0.56 to 2.83
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Hide Description [Not Specified]
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: percent change
-1.72
(-3.27 to -0.18)
-2.56
(-4.54 to -0.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
-1.67 to 3.35
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Total Number of Respiratory Infections
Hide Description [Not Specified]
Time Frame Randomization to up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Measure Type: Number
Unit of Measure: respiratory infections
34 49
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.46 to 1.11
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in UCSD-Shortness of Breath Questionnaire
Hide Description Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living.
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
5.67
(2.75 to 8.59)
6.29
(3.54 to 9.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-4.64 to 3.39
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Fatigue Severity Scale Score
Hide Description Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle.
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
0.24
(-0.02 to 0.49)
0.13
(-0.12 to 0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.24 to 0.46
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Leicester Cough Questionnaire Score
Hide Description Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough.
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.58
(-1.15 to 0.00)
-0.58
(-1.13 to -0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.79 to 0.80
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in EuroQol Index (EQ-5D) Score
Hide Description European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression.
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.040
(-0.071 to -0.009)
-0.046
(-0.075 to -0.016)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-4.64 to 3.39
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score
Hide Description Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people.
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
0.027
(-0.003 to 0.057)
0.017
(-0.011 to 0.045)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.010
Confidence Interval (2-Sided) 95%
-0.031 to 0.051
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in Short Form-12 Health Survey (SF-12) 6D Score
Hide Description Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation.
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.013
(-0.031 to 0.005)
-0.031
(-0.048 to -0.014)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.018
Confidence Interval (2-Sided) 95%
-0.007 to 0.043
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change in Short Form-12 Health Survey (SF-12) Physical Score
Hide Description

Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.

The short form-12 health survey physical score assesses limitations in physical activities because of health problems.

Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-1.36
(-2.54 to -0.18)
-1.88
(-3.00 to -0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-1.11 to 2.15
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change in SF-12 Health Survey (SF-12) Mental Score
Hide Description

Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.

The short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health.

Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description:

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

Overall Number of Participants Analyzed 254 259
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-1.29
(-2.67 to 0.09)
-1.59
(-2.91 to -0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.61 to 2.20
Estimation Comments [Not Specified]
Time Frame Thirty-five months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antimicrobial Therapy Plus Standard of Care Standard of Care
Hide Arm/Group Description

Co-trimoxazole OR doxycycline

Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months

Standard of care for patients with IPF for comparison

No Intervention: Standard of Care: Standard of care

All-Cause Mortality
Antimicrobial Therapy Plus Standard of Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   37/254 (14.57%)      37/259 (14.29%)    
Hide Serious Adverse Events
Antimicrobial Therapy Plus Standard of Care Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/254 (27.95%)      65/259 (25.10%)    
Cardiac disorders     
Cardiac disorder   11/254 (4.33%)  12 11/259 (4.25%)  11
Endocrine disorders     
Endocrine disorders   1/254 (0.39%)  1 0/259 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal disorder   3/254 (1.18%)  3 4/259 (1.54%)  4
General disorders     
General disorders and administrative site conditions   5/254 (1.97%)  6 1/259 (0.39%)  1
Hepatobiliary disorders     
Hepatobiliary disorders   2/254 (0.79%)  2 0/259 (0.00%)  0
Immune system disorders     
Immune system disorders   0/254 (0.00%)  0 1/259 (0.39%)  1
Infections and infestations     
Pneumonia   5/254 (1.97%)  5 7/259 (2.70%)  7
Infections and infestations   7/254 (2.76%)  9 17/259 (6.56%)  17
Injury, poisoning and procedural complications     
Injury, poisoning, and procedural complications   2/254 (0.79%)  2 1/259 (0.39%)  1
Investigations     
Investigations   0/254 (0.00%)  0 1/259 (0.39%)  2
Metabolism and nutrition disorders     
Metabolic and nutrition disorders   2/254 (0.79%)  2 4/259 (1.54%)  4
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorder   2/254 (0.79%)  2 3/259 (1.16%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm benign, malignant, and unspecified   1/254 (0.39%)  1 1/259 (0.39%)  1
Nervous system disorders     
Nervous system disorder   8/254 (3.15%)  8 3/259 (1.16%)  3
Syncope   3/254 (1.18%)  3 0/259 (0.00%)  0
Product Issues     
Product issues   0/254 (0.00%)  0 1/259 (0.39%)  1
Renal and urinary disorders     
Renal and urinary disorders   2/254 (0.79%)  2 1/259 (0.39%)  1
Respiratory, thoracic and mediastinal disorders     
Idiopathic pulmonary fibrosis   14/254 (5.51%)  16 5/259 (1.93%)  6
Respiratory failure   4/254 (1.57%)  4 4/259 (1.54%)  4
Dyspnea   5/254 (1.97%)  5 2/259 (0.77%)  2
Pulmonary embollism   2/254 (0.79%)  2 3/259 (1.16%)  3
Respiratory, thoracic and mediastinal disorders   42/254 (16.54%)  51 26/259 (10.04%)  29
Vascular disorders     
Vascular disorders   3/254 (1.18%)  3 1/259 (0.39%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Antimicrobial Therapy Plus Standard of Care Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/254 (24.41%)      23/259 (8.88%)    
Cardiac disorders     
Arrhythmia   2/254 (0.79%)  2 5/259 (1.93%)  5
Gastrointestinal disorders     
Vomiting   12/254 (4.72%)  14 2/259 (0.77%)  2
Diarrhea   26/254 (10.24%)  29 8/259 (3.09%)  8
General disorders     
Other   8/254 (3.15%)  8 7/259 (2.70%)  7
Metabolism and nutrition disorders     
Hyperkalemia   10/254 (3.94%)  11 2/259 (0.77%)  2
Skin and subcutaneous tissue disorders     
Rash   17/254 (6.69%)  22 0/259 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth Peters
Organization: Weill Cornell Medicine
Phone: 646-962-2742
EMail: elp2018@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02759120    
Other Study ID Numbers: 1504016087
U01HL128954 ( U.S. NIH Grant/Contract )
First Submitted: April 28, 2016
First Posted: May 3, 2016
Results First Submitted: December 22, 2020
Results First Posted: March 3, 2021
Last Update Posted: April 8, 2021