CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00985582
NCT00985582N/ACompleted

Antiviral Treatment in Adults and Children With Novel Influenza A (H1N1) Respiratory Tract Infection - a Clinical, Virological and Pharmacokinetic Study.

South East Asia Infectious Disease Clinical Research Network·observational·Posted Sep 28, 2009·Updated May 27, 2011

In Brief

An observational study for Influenza A Virus Infection. Completed, enrolled 181 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesVietnam
CollaboratorsWellcome Trust

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.8 years ago