A Phase 3 interventional study of oseltamivir + zanamivir and oseltamivir + zanamivir's placebo in Gastric Influenza, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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)
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 541 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
oral oseltamivir 75mg twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 days
Drug: oseltamivir + zanamivir
oral oseltamivir 75mg twice daily+ placebo inhaled by mouth twice daily during 5 days
Drug: oseltamivir + zanamivir's placebo
oral placebo twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 day
Drug: oseltamivir's placebo + zanamivir
oral oseltamivir 75mg twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 days
Also known as: experimental Arm
oral oseltamivir 75mg twice daily+ placebo inhaled by mouth twice daily during 5 day
Also known as: Active comparator Arm
oral placebo twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 day
Also known as: active comparator arm
RT-PCR for influenza A virus in nasal secretion
Time frame: 2 days
Time to resolution of influenzal illness Severity of illness
Time frame: 14 days
Severity of illness
Time frame: 14 Days
Adverse event (graded on a four -point scale:mild-moderate- severe-life threatening)
Time frame: 14 days
Compliance to antiviral treatment
Time frame: 14 days
Number of persons with influenza illness in households contact
Time frame: 14 days
Evaluation of restricted activity (requirement for additional health car)
Time frame: 14 days
Frequency of and need for antibiotic treatment of influenza (otitis media, bronchitis, sinusitis, and pneumonia )
Time frame: 14 days
Frequency of resistance to antiviral drugs
Time frame: 14 days
This study is terminated, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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