Plasma Levels of Oseltamivir in critically ill, suspected or confirmed H1N1 infected patients on Extra Corporeal membrane Oxygenation (ECMO)support. - Plasma levels of Oseltamivir in patients on ECMO

• Conditions: Treatment of confirmed or suspected H1N1 (swine flu) infection in critically ill patients supported on ECMO

• Registration Number: EUCTR2009-018200-17-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients, both adults and children, admitted to Glenfield hospital for ECMO treatment for suspected or confirmed H1N1 Influenza and on /or requiring Oseltamivir treatment. This will be done after informed consent has been agreed with the Parents/guardians/relatives of the patients.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Where parents/guardians/relatives refuse consent, those patients will be excluded from the study. There will be no other exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. Assess plasma levels of oseltamivir in children and adults with suspected or confirmed H1N1 infection and supported on ECMO.<br>2. Determine pharmacokinetics of Osteltamavir in children and adults undergoing ECMO treatment.<br>3. Determine optimum dosage of Oseltamivir for treatment of H1N1 infections in ECMO patients.<br>;Secondary Objective: None;Primary end point(s): The primary outcome measure is to determine the Pharmacokinetic parameters (clearance, volume of distribution and half life) of Oseltamivir administered to patients treated on ECMO support.