Status:
TERMINATED
Efficacy and Safety of Combination Therapies With Oseltamivir & Zanamivir or Oseltamivir & Amantadine Versus Oseltamivir Monotherapy in the Treatment of Seasonal Influenza A Infection
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Influenza A Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Neuraminidase inhibitors (NAI) are effective anti-influenza antiviral treatment. During their use in experimentally infected patients, it has been shown that the viral load detected in the nasal fluid...
Detailed Description
Study Schedule: * Patient's follow up: 7 days with 10 visits V1, V2, V3, V4, V5 every 12 hours V6, V7, V8, V9, V10 every 24 hours * V1: conducted by the GP rapid test diagnostic for influenza A, urin...
Eligibility Criteria
Inclusion
- Influenza season declared
- Subjects aged\>18 years and \< 65 years presenting within 36h documented of onset influenza illness
- Who have fever \>38°C
- Who present at least one 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
- Primary care follow up
Exclusion
- Influenza Vaccination in the 12 months prior the beginning of the study
- Asthma, Chronic bronchitis
- Woman with a positive urine pregnancy test
- Active breast feeding
- Woman without contraception
- Clearance of creatinine\< 30 ml/min Chronic renal disease
- History of depression, psychiatric disorders, epilepsy
- Patients receiving cortocosteroids, immunosuppressants or antipsychotic antiemetic drugs
- Known oseltamivir or zanamivir hypersensibility
- Non member of the social security or CMU
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00830323
Start Date
January 1 2009
End Date
August 1 2009
Last Update
September 30 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospices civils de Lyon
Lyon, France