A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

Completed · Phase 4 · Has a placebo group

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00412737

Run by

Hoffmann-La Roche

People needed

477

Starts

2007-01-01

Expected to finish

2008-05-01

Last updated by the study team

2016-06-10

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Brooklyn Center, Minnesota, United States
• Study site — Missoula, Montana, United States
• Study site — Camden, New Jersey, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Livingston, New Jersey, United States
• Study site — Newark, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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