A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
Status:
Terminated
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in
3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection.
Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days.
Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous
dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at
day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration.
Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.