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Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir

NCT00799760 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2012-03-19

No results posted yet for this study

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.

Conditions

  • Gastric Influenza

Interventions

DRUG

oseltamivir + zanamivir

oral oseltamivir 75mg twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 days

DRUG

oseltamivir + zanamivir's placebo

oral oseltamivir 75mg twice daily+ placebo inhaled by mouth twice daily during 5 day

DRUG

oseltamivir's placebo + zanamivir

oral placebo twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 day

Sponsors & Collaborators

Principal Investigators

  • Catherine LEPORT, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-11-30
Completion
2010-11-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799760 on ClinicalTrials.gov