drugset / Trial / NCT00949533
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
RandomizedParallel-groupOpen-labelTreatment
Summary
This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oseltamivir | Small molecule | 30 mg | Oral |
| Subject | Oseltamivir | Small molecule | 60 mg | Oral |
| Subject | Oseltamivir | Small molecule | 75 mg | Oral |
| Subject | Oseltamivir | Small molecule | 150 mg | Oral |