Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: GlaxoSmithKline; Hoffmann-La Roche
• Treatments: Oseltamivir; Zanamivir

Criteria

Inclusion Criteria:

• Influenza season declared

• Subjects aged>18 years presenting within 36h documented of onset influenza illness

• Who have fever >38°C

• who present at least on of the following respiratory symptoms( cough, sore throat, nasal symptoms)

• and one of the following constitutional symptoms(headache, myalgia, sweats and or chills or fatigue)

• positive rapid diagnostic test for influenza A

• who have giving written informed consent prior to enrollment

• Patient examined before the inclusion

• able to complete a questionnaire.

Exclusion Criteria:

• Influenza Vaccination in the 12 months prior the beginning of the study

• Patient unable to use diskhaler of Zanamivir

• Asthma, Chronic bronchitis,

• Woman with a positive urine pregnancy test

• Clearance of creatinine< 30 ml/min Chronic renal disease

• History of depression, psychiatric disorders

• oseltamivir or zanamivir hypersensibility

• patient treated by oseltamivir or zanamivir or amantadine 14 days before

• Non member of the social security or CMU