Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir
Status:
Terminated
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
In order to prevent the high mortality due to an hypothetic pandemic caused by a newly
emerging influenza A virus, antiviral drugs are seen as essential requirements for control of
initial influenza outbreaks.Two antivirals are available for the treatment oseltamivir and
zanamivir. Emergence of Oseltamivir resistance has been recently reported. . It appeared
opportune to assess the efficacy and safety of biotherapy of neuraminidase inhibitors ,will
be investigated by a randomized, placebo controlled, double blind study in France, during the
next winter season . This study will be conducted in 300 centres of primary care with 900
adults with a virologically suspected influenza A infection. Individuals will be randomized
to 1 of the 3 treatment groups: oseltamivir +zanamivir, or oseltamivir+placebo or placebo
+zanamivir.The primary judgment criteria will be the proportion of patients with negative RT
PCR negative in nasal secretions at Day 2.