Clinical trial NCT00412737: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 477
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Secondary outcomes:
measure: Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
measure: Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
measure: Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
measure: Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
measure: Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
measure: Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
timeFrame: From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: St Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Missoula
country: United States
state: Montana
city: Camden
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Livingston
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Aalst
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Coquitlam
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Brno
country: Czech Republic
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Budapest
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Padova
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Bialystok
country: Poland
city: Lodz
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Birmingham
country: United Kingdom
city: Edinburgh
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.