Status:
TERMINATED
Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Hoffmann-La Roche
GlaxoSmithKline
Conditions:
Gastric Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Detailed Description
In the near future, a pandemic caused by a newly emerging influenza A virus has been predicted by the WHO. In order to prevent the high mortality due to the pandemic, antiviral drugs are seen as essen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT00799760
Start Date
December 1 2008
End Date
November 1 2010
Last Update
March 19 2012
Active Locations (1)
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1
Centre Investigateur 155
Deûlémont, France, 59000