MedTrace Logo

Antiviral Therapy for Influenza A H1N1

NCT00985582 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 181

Last updated 2011-05-27

No results posted yet for this study

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

Conditions

  • Influenza A Virus Infection

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • South East Asia Infectious Disease Clinical Research Network

    lead NETWORK

Principal Investigators

  • Jeremy Farrar, MD · Oxford University Clinical Research Unit Ho Chi Minh City Vietnam

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985582 on ClinicalTrials.gov