Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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 essential requirements for control of initial influenza outbreaks.

Zanamivir (GSK) and Oseltamivir (Roche) are stockpiled by the French government in the setting of pre-pandemic plan. In France, Zanamivir and Oseltamivir are both registered for the prophylactic and therapeutic use against influenza A.

Previous studies have shown that neuraminidase inhibitors (oseltamivir and zanamivir, based treatment) are associated with shorter illness duration and resulted in significant decrease of viral load in the nasal secretions.

In Winter season 2007-2008 the presence of oseltamivir-resistant viruses circulating in the community in several European countries is in marked contrast to the previous winter seasons, when oseltamivir resistance was detected in \<1% of circulating strains from . Patients infected by viruses with neuraminidases carrying these mutations, didn't present unusual disease syndromes.

Although zanamivir and oseltamivir are both issued from the same class ,a combination of these two neuraminidase inhibitors could reduce the duration and severity of acute influenza and the incidence of secondary complications, reduce the spread of influenza, and the frequency of neuraminidase inhibitors mutations. An evaluation of the combination of oseltamivir and zanamivir versus zanamivir with placebo versus oseltamivir associated with placebo in the treatment of a virologically suspected influenza in primary care will be investigated in a randomised double blind placebo controlled trial study in France during the winter season 2008-2009.

Primary outcome measure:

Evaluate viral efficacy after 2 days of biotherapy oseltamivir and zanamivir versus zanamivir with placebo versus oseltamivir associated with placebo.

Patients and methods:

Randomised double blind, placebo controlled multicenter trial conducted during the influenza season 2008-2009 Arm 1: oral oseltamivir 75mg twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 days Arm 2: oral oseltamivir 75mg twice daily+ placebo inhaled by mouth twice daily during 5 days Arm 3: oral placebo twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 days.

Schedule:

D0: rapid test diagnostic for influenza A urine pregnancy test for women inclusion /randomisation initiation of treatment D2:nasal sample for influenza RNA RTPCR D5:End of treatment D7:medical evaluation (follow up evaluation) D14:nurse call (clinical evaluation)

Conditions

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Gastric Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

oseltamivir + zanamivir

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

oseltamivir + zanamivir's placebo

Intervention Type DRUG

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

3

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

Group Type ACTIVE_COMPARATOR

oseltamivir's placebo + zanamivir

Intervention Type DRUG

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

Interventions

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oseltamivir + zanamivir

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

Intervention Type DRUG

oseltamivir + zanamivir's placebo

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

Intervention Type DRUG

oseltamivir's placebo + zanamivir

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

Intervention Type DRUG

Other Intervention Names

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experimental Arm Active comparator Arm active comparator arm

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No