A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
This partially randomized, multi-center parallel-group study will evaluate the safety,
pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in
patients with influenza. Adult and adolescent patients will be randomized to receive either
100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are
blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral
Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days,
with an optional treatment extension of a further 5 days, if necessary. There will be a
non-randomized, open-label treatment group for patients with moderate/severe renal impairment
or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to
their renal situation.