Back to resultsA Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Oseltamivir
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Negative rapid diagnostic test for influenza at baseline;
- Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
Exclusion Criteria:
- Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
- Influenza vaccination in 6 weeks prior to randomization;
- Positive rapid diagnostic test for influenza;
- Solid organ transplant within 6 months of randomization;
- Antiviral treatment for influenza in 2 weeks prior to randomization.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oseltamivir
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Secondary Outcome Measures
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00412737
Brief Title
A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
Official Title
A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
477 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oseltamivir
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
Description
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
Description
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Title
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
Description
Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Title
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
Description
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Title
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
Description
RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Title
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
Description
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Title
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
Description
RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.
Time Frame
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Negative rapid diagnostic test for influenza at baseline;
Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
Exclusion Criteria:
Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
Influenza vaccination in 6 weeks prior to randomization;
Positive rapid diagnostic test for influenza;
Solid organ transplant within 6 months of randomization;
Antiviral treatment for influenza in 2 weeks prior to randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106-3316
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7211
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-44A1
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 0Z9
Country
Canada
City
Brno
ZIP/Postal Code
639 00
Country
Czech Republic
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Paris
ZIP/Postal Code
75019
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75743
Country
France
City
Toulouse
ZIP/Postal Code
31054
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Aachen
ZIP/Postal Code
52057
Country
Germany
City
Berlin
ZIP/Postal Code
10098
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
München
ZIP/Postal Code
80336
Country
Germany
City
München
ZIP/Postal Code
81675
Country
Germany
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22728756
Citation
Ison MG, Szakaly P, Shapira MY, Krivan G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.
Results Reference
derived
Links:
URL
http://www.roche-trials.com/studyResultGet.action?studyResultNumber=NV20235
Description
Clinical Study Report Synopsis
Learn more about this trial
A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
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