Treatment of confirmed or suspected H1N1 (swine flu) infection in critically ill patients supported on ECMO
Conditions
Interventions
Trade Name: Oseltamivir (Tamiflu) 12mg/ml powder for oral suspension
Product Name: Tamiflu (oseltamivir)
Pharmaceutical Form: Powder for oral suspension
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Where parents/guardians/relatives refuse consent, those patients will be excluded from the study. There will be no other exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Assess plasma levels of oseltamivir in children and adults with suspected or confirmed H1N1 infection and supported on ECMO. 2. Determine pharmacokinetics of Osteltamavir in children and adults undergoing ECMO treatment. 3. Determine optimum dosage of Oseltamivir for treatment of H1N1 infections in ECMO patients. ;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. | — |
Countries
United Kingdom
Outcome results
None listed