A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants
A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
1 other identifier
interventional
477
13 countries
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
September 9, 2009
CompletedJune 10, 2016
May 1, 2016
1.3 years
December 15, 2006
August 3, 2009
May 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Secondary Outcomes (6)
Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
- +1 more secondary outcomes
Study Arms (2)
Oseltamivir
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- Negative rapid diagnostic test for influenza at baseline;
- Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Unknown Facility
Birmingham, Alabama, 35233, United States
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Little Rock, Arkansas, 72202, United States
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Stanford, California, 94305, United States
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Denver, Colorado, 80262, United States
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Hartford, Connecticut, 06106-3316, United States
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Newark, Delaware, 19718, United States
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St. Petersburg, Florida, 33701, United States
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Atlanta, Georgia, 30309, United States
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Augusta, Georgia, 30912, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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New Orleans, Louisiana, 70121, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202-2689, United States
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Brooklyn Center, Minnesota, 55430, United States
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Missoula, Montana, 59802, United States
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Camden, New Jersey, 08103, United States
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Hackensack, New Jersey, 07601, United States
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Livingston, New Jersey, 07039, United States
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Newark, New Jersey, 07112, United States
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Buffalo, New York, 14263, United States
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New York, New York, 10023, United States
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New York, New York, 10032, United States
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Chapel Hill, North Carolina, 27599-7211, United States
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Charlotte, North Carolina, 28207, United States
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Durham, North Carolina, 27705, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44195, United States
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Oklahoma City, Oklahoma, 73112-44A1, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Dallas, Texas, 75203, United States
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Houston, Texas, 77030, United States
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Aalst, 9300, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Edmonton, Alberta, T6G 2B7, Canada
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Coquitlam, British Columbia, V3K 3P4, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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London, Ontario, N6A 5A5, Canada
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Saskatoon, Saskatchewan, S7M 0Z9, Canada
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Brno, 639 00, Czechia
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Tallinn, 10617, Estonia
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Tartu, 51014, Estonia
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Paris, 75019, France
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Paris, 75475, France
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Paris, 75743, France
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Toulouse, 31054, France
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Tours, 37044, France
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Aachen, 52057, Germany
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Berlin, 10098, Germany
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Hamburg, 20251, Germany
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Heidelberg, 69120, Germany
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München, 80336, Germany
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München, 81675, Germany
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Budapest, 1097, Hungary
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Pécs, 7624, Hungary
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Szeged, 6720, Hungary
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Roma, 00168, Italy
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Kaunas, 50009, Lithuania
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Vilnius, 08661, Lithuania
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Bialystok, 15-540, Poland
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Lodz, 90-153, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-006, Poland
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Warsaw, 04-730, Poland
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Madrid, 28006, Spain
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Madrid, 28040, Spain
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Birmingham, B15 2TH, United Kingdom
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Edinburgh, EH16 4SA, United Kingdom
Related Publications (1)
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.
PMID: 22728756DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no overall limitations and caveats.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
January 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
June 10, 2016
Results First Posted
September 9, 2009
Record last verified: 2016-05