Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 118 for:    oseltamivir

ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

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: NCT02609399
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Results First Posted : June 20, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Influenza
Interventions Drug: Oseltamivir
Drug: Peramivir
Enrollment 180
Recruitment Details

This study recruited adult patients through both clinical testing and screening with a Clinical Decision Guideline (CDG) over two influenza seasons at the following academically affiliated U.S. Emergency Departments (EDs):

  • November 2015- April 2016: Johns Hopkins Hospital (JHH)
  • November 2016- April 2017: JHH and Maricopa Medical Center (MMC)
Pre-assignment Details  
Arm/Group Title Oseltamivir Peramivir
Hide Arm/Group Description Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir. Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
Period Title: Influenza Season 2015-2016
Started 27 31
Completed 24 29
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             3             2
Period Title: Influenza Season 2016-2017
Started 58 64
Completed 49 59
Not Completed 9 5
Reason Not Completed
Lost to Follow-up             8             5
Found ineligible after randomization             1             0
Arm/Group Title Experimental: Oseltamivir Experimental: Peramivir Total
Hide Arm/Group Description Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir. Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. Total of all reporting groups
Overall Number of Baseline Participants 84 95 179
Hide Baseline Analysis Population Description
For baseline analyses, overall characteristics (seasons 2015-2016 & 2016-2017) & characteristics stratified by influenza season (2015-2016 vs. 2016-2017) are presented. Total number of subjects contributing data to 2015-2016 baseline analyses was 58, compared to 121 subjects for 2016-2017 season. Information unavailable: 1 oseltamivir participant
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 95 participants 179 participants
47.3
(20 to 78)
47.5
(19 to 80)
47.4
(19 to 80)
[1]
Measure Description: Baseline measures includes both influenza seasons 2015-2016 and 2016-2017. A total of 180 subjects were enrolled across both seasons. Baseline information is unavailable for 1 participant in the oseltamivir arm
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 95 participants 179 participants
Female
48
  57.1%
58
  61.1%
106
  59.2%
Male
36
  42.9%
37
  38.9%
73
  40.8%
[1]
Measure Description: Baseline measures includes both influenza seasons 2015-2016 and 2016-2017. A total of 180 subjects were enrolled across both seasons. Baseline information is unavailable for 1 participant in the oseltamivir arm
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 95 participants 179 participants
Hispanic or Latino
10
  11.9%
19
  20.0%
29
  16.2%
Not Hispanic or Latino
74
  88.1%
76
  80.0%
150
  83.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Baseline measures includes both influenza seasons 2015-2016 and 2016-2017. A total of 180 subjects were enrolled across both seasons. Baseline information is unavailable for 1 participant in the oseltamivir arm
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 95 participants 179 participants
American Indian or Alaska Native
1
   1.2%
2
   2.1%
3
   1.7%
Asian
2
   2.4%
1
   1.1%
3
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
60
  71.4%
60
  63.2%
120
  67.0%
White
21
  25.0%
29
  30.5%
50
  27.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
   3.2%
3
   1.7%
[1]
Measure Description: Baseline measures includes both influenza seasons 2015-2016 and 2016-2017. A total of 180 subjects were enrolled across both seasons. Baseline information is unavailable for 1 participant in the oseltamivir arm
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 84 participants 95 participants 179 participants
84 95 179
Age, Continuous (Influenza Season 2015-2016)   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 31 participants 58 participants
48.7
(20 to 68)
43.7
(19 to 72)
46
(19 to 72)
[1]
Measure Analysis Population Description: This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
Age, Continuous (Influenza Season 2016-2017)   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 57 participants 64 participants 121 participants
46.6
(20 to 78)
49.3
(20 to 80)
48.0
(20 to 80)
[1]
Measure Analysis Population Description: This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm.
Sex: Female, Male (Influenza Season 2015-2016)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 31 participants 58 participants
Female
11
  40.7%
17
  54.8%
28
  48.3%
Male
16
  59.3%
14
  45.2%
30
  51.7%
[1]
Measure Analysis Population Description: This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
Sex: Female, Male (Influenza Season 2016-2017)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 64 participants 121 participants
Female
37
  64.9%
41
  64.1%
78
  64.5%
Male
20
  35.1%
23
  35.9%
43
  35.5%
[1]
Measure Analysis Population Description: This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
Ethnicity (NIH/OMB) (Influenza Season 2015-2016)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 31 participants 58 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
27
 100.0%
31
 100.0%
58
 100.0%
[1]
Measure Analysis Population Description: This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
Ethnicity (NIH/OMB) (Influenza Season 2016-2017)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 64 participants 121 participants
Hispanic or Latino
10
  17.5%
19
  29.7%
29
  24.0%
Not Hispanic or Latino
47
  82.5%
45
  70.3%
92
  76.0%
[1]
Measure Analysis Population Description: This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
Race (NIH/OMB) (Influenza Season 2015-2016)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 31 participants 58 participants
American Indian or Alaska Native
0
   0.0%
1
   3.2%
1
   1.7%
Asian
0
   0.0%
1
   3.2%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  81.5%
24
  77.4%
46
  79.3%
White
5
  18.5%
5
  16.1%
10
  17.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: This measure is specific to the 2015-2016 influenza season, during which 58 subjects were enrolled and analyzed.
Race (NIH/OMB) (Influenza Season 2016-2017)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 64 participants 121 participants
American Indian or Alaska Native
1
   1.8%
1
   1.6%
2
   1.7%
Asian
2
   3.5%
0
   0.0%
2
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
38
  66.7%
36
  56.3%
74
  61.2%
White
16
  28.1%
24
  37.5%
40
  33.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
   4.7%
3
   2.5%
[1]
Measure Analysis Population Description: This measure is specific to the 2016-2017 influenza season, during which 122 subjects were enrolled and analyzed. Baseline information is unavailable for 1 participant in the oseltamivir arm
1.Primary Outcome
Title Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire
Hide Description

Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms.

Item responses:

  1. Not at all
  2. A little bit
  3. Somewhat
  4. Quite a bit
  5. Very much
Time Frame ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled and randomized.
Arm/Group Title Oseltamivir Peramivir
Hide Arm/Group Description:
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
Overall Number of Participants Analyzed 27 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Nose 1.4  (0.8) 1.9  (1.3)
Throat 1.3  (0.8) 1.7  (1.2)
Eyes 1.2  (0.6) 1.6  (1.2)
Chest/Respiratory 1.9  (1.2) 2.3  (1.5)
Gastrointestinal 1.5  (1.1) 1.5  (1.1)
Body/Systemic 1.7  (1.2) 1.9  (1.4)
Total/Overall 1.6  (1.1) 1.9  (1.4)
2.Primary Outcome
Title Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire
Hide Description

Symptom evaluation during the 2016-2017 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms.

Item responses:

  1. Not at all
  2. A little bit
  3. Somewhat
  4. Quite a bit
  5. Very much
Time Frame ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)
Arm/Group Title Oseltamivir Peramivir
Hide Arm/Group Description:
Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
Overall Number of Participants Analyzed 57 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
Nose 1.5  (0.8) 1.5  (0.7)
Throat 1.3  (0.6) 1.4  (0.8)
Eyes 1.3  (0.7) 1.2  (0.5)
Chest/Respiratory 1.7  (0.8) 1.8  (0.9)
Gastrointestinal 1.3  (0.7) 1.3  (0.7)
Body/Systemic 1.5  (0.8) 1.5  (0.8)
Total/Overall 1.4  (0.6) 1.5  (0.6)
3.Primary Outcome
Title Mean Karnofsky Performance Scale Score During the 2015-2016 Influenza Season
Hide Description

The Karnofsky Performance Scale is a tool for assessing subject functional impairment.

Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal – no complaints, no evidence of disease) from enrollment through Day 14 of the 2015-2016 influenza season.

Time Frame ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled and randomized.
Arm/Group Title Experimental: Oseltamivir Experimental: Peramivir
Hide Arm/Group Description:
Subjects randomized to the oral treatment arm received 5 days of oral oseltamivir.
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
Overall Number of Participants Analyzed 27 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.1  (20.8) 73.2  (19.9)
4.Primary Outcome
Title Mean Karnofsky Performance Scale Score During the 2016-2017 Influenza Season
Hide Description

The Karnofsky Performance Scale is a tool for assessing subject functional impairment.

Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal – no complaints, no evidence of disease) from enrollment through Day 14 of the 2016-2017 influenza season.

Time Frame ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)
Arm/Group Title Experimental: Oseltamivir Experimental: Peramivir
Hide Arm/Group Description:
Subjects randomized to the oral treatment arm received 5 days of oral oseltamivir.
Subjects randomized to the IV treatment group will receive 1 dose of IV peramivir. (Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician).
Overall Number of Participants Analyzed 57 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
80.0  (10.7) 79.9  (9.1)
Time Frame Accrual for the 2015-2016 influenza season opened on 11/1/2015 and closed on 4/30/2016. Accrual for the 2016-2017 influenza season opened on 11/1/2016 and closed on 4/30/2017. All enrolled participants were assessed for adverse events from enrollment visit until the end of study follow up on Day 28.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oseltamivir Peramivir
Hide Arm/Group Description

Subjects randomized to the oral treatment arm will receive 5 days of oral oseltamivir.

Oseltamivir: Oral

Subjects randomized to the IV treatment group will receive 1 dose (or more as appropriate at the discretion of the treating physician) of IV peramivir.

Peramivir: IV

Note: Should a patient remain in the hospital after 5 days of treatment, and the patient is symptomatically better, treatment will stop. If the patient remains hospitalized after 5 days of treatment and has not improved, the treating physician will continue to have an option to continue use of peramivir daily for another 5 day course.

All-Cause Mortality
Oseltamivir Peramivir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)      0/95 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oseltamivir Peramivir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/84 (4.76%)      9/95 (9.47%)    
Cardiac disorders     
Myocardial infarction   0/84 (0.00%)  0 1/95 (1.05%)  1
Coronary artery disease   0/84 (0.00%)  0 1/95 (1.05%)  1
Gastrointestinal disorders     
Intestinal perforation  1  1/84 (1.19%)  1 0/95 (0.00%)  0
Investigations     
Blood creatinine increased   1/84 (1.19%)  1 0/95 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Abdominal Pain   0/84 (0.00%)  0 1/95 (1.05%)  1
Nervous system disorders     
Syncope   0/84 (0.00%)  0 1/95 (1.05%)  1
Facial paralysis   0/84 (0.00%)  0 1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma   1/84 (1.19%)  1 0/95 (0.00%)  0
Pneumonia   1/84 (1.19%)  1 0/95 (0.00%)  0
Pulmonary embolism   0/84 (0.00%)  0 1/95 (1.05%)  1
Chronic obstructive pulmonary disease (COPD)   0/84 (0.00%)  0 1/95 (1.05%)  1
Surgical and medical procedures     
Pre-op admission   0/84 (0.00%)  0 1/95 (1.05%)  1
Vascular disorders     
Hypotension   0/84 (0.00%)  0 2/95 (2.11%)  2
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oseltamivir Peramivir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/84 (58.33%)      54/95 (56.84%)    
Ear and labyrinth disorders     
Vertigo   9/84 (10.71%)  9 10/95 (10.53%)  12
Gastrointestinal disorders     
Diarrhea  1  28/84 (33.33%)  32 31/95 (32.63%)  36
Nausea   27/84 (32.14%)  29 21/95 (22.11%)  23
Vomiting   19/84 (22.62%)  20 16/95 (16.84%)  17
Nervous system disorders     
Confusion/Hallucinations   6/84 (7.14%)  6 7/95 (7.37%)  7
Psychiatric disorders     
Insomnia   12/84 (14.29%)  14 18/95 (18.95%)  18
Skin and subcutaneous tissue disorders     
Rash   7/84 (8.33%)  8 5/95 (5.26%)  6
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
  1. Not designed or powered to assess differences in clinical outcomes.
  2. Planned to recruit >= 50 subjects/site, but MMC enrolled 44 due to lower-than-expected flu incidence and Hopkins Uni. increased enrollment to make up for the shortfall.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Richard Rothman
Organization: Johns Hopkins University
Phone: 410-735-6428
EMail: rrothma1@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02609399     History of Changes
Other Study ID Numbers: IRB00080405
1 IDSEP150026-01-00 ( Other Grant/Funding Number: Department of Health and Human Services )
1 IDSEP160031-01-00 ( Other Grant/Funding Number: Department of Health and Human Services )
First Submitted: October 27, 2015
First Posted: November 20, 2015
Results First Submitted: April 11, 2018
Results First Posted: June 20, 2018
Last Update Posted: November 30, 2018