Overview
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Status:
Completed
Completed
Trial end date:
2010-10-01
2010-10-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Oseltamivir
Criteria
Inclusion Criteria:- positive rapid antigen test for influenza A
- onset of symptoms of influenza (fever, at least one respiratory symptom) =48 hours
Exclusion Criteria:
- clinical suspicion of infection with a respiratory virus other than influenza
- suspicion of invasive bacterial infection
- evidence of poorly controlled underlying disease
- known immunosuppression
- known allergy to Oseltamivir
- women who are pregnant or planning to get pregnant during the study