Trials / Completed
CompletedNCT00545532
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 228 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | oseltamivir | Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days |
| OTHER | placebo | Placebo matched to oseltamivir po twice daily for 10 days |
Timeline
- Start date
- 2008-02-04
- Primary completion
- 2017-05-02
- Completion
- 2017-05-02
- First posted
- 2007-10-17
- Last updated
- 2018-07-12
- Results posted
- 2018-07-12
Locations
208 sites across 26 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Romania, South Africa, Spain, Switzerland, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00545532. Inclusion in this directory is not an endorsement.