Influenza A Virus Infection Clinical Trial
Official title:
Antiviral Treatment in Adults and Children With Novel Influenza A (H1N1) Respiratory Tract Infection - a Clinical, Virological and Pharmacokinetic Study.
The aims of this study are to characterise the clinical efficacy and virological clearance
dynamics of orally administered oseltamivir in patients with influenza caused by novel
influenza A(H1N1). This research will also contribute to enhancing research capacity in
affected countries.
The objectives are to assess the:
- viral replication levels over time in affected patients
- antiviral efficacy of oral oseltamivir
- patterns and compartments of viral shedding, tissue distribution
- innate inflammatory response and relation to viral replication
- kinetics of antibody response
- antiviral sensitivity of influenza viruses at baseline and during oseltamivir treatment
using in vitro and molecular methods
- pharmacokinetic characteristics of oseltamivir and oseltamivir carboxylate
- all cause in hospital mortality
- clinical and radiological features, disease course and outcome
- length of stay in hospital
- risk factors associated with development of severe disease and death
Any patient over 1 year of age who presents to a participating institution with confirmed
influenza A and who meets the study inclusion/exclusion criteria may be approached for
informed consent. Choice of antiviral is up to the study physician. Children aged 1-6 years
and asthmatics should receive oseltamivir. The weight- and age-adjusted dosage used will be
that approved for treatment of uncomplicated seasonal influenza, and doses will be
administered twice daily for 5 days for patients with normal renal function. All patients
who are clinical and/or virologic failures at day 5 will be treated for an additional 5 days
of antivirals. After coming off antiviral therapy patients can be discharged at day 10 if
deemed ready by study physicians and they are virologically negative.
During the course of treatment study evaluations will be performed to determine primary
efficacy end points including viral clearance on Day 5 on all collected nasopharyngeal
samples, assessed by RT PCR for novel H1N1 influenza AND no clinical features of clinical
failure. Evaluations will also be performed to determine secondary viral, serological,
clinical efficacy, safety and pharmacokinetic endpoints.
Patients will be followed up for up to 6 months after discharge for a clinical assessment,
pulmonary function and outcome of pregnancy.
The protocol will be reviewed after 6 months from starting or after 100 patients with
Influenza A are recruited.
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Observational Model: Case-Only, Time Perspective: Prospective
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