Plasma levels of Oseltamivir in patients on ECMO

• Research type

  Research Study

• Full title

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

• IRAS ID

  38430

• Contact name

  Raghu Ramaiah

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Eudract number

  2009-018200-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is an observational cohort study in a group of very sick patients who require prolonged cardio-pulmonary (ECMO) support for severe swine flu infection. As well as other therapy the principle drug treatment is Oseltamivir (Taflu administered orally using a naso-gastric tube. However, whereas the dose for Oseltamivir is studied and established in ‘normal’ patients, the effective dose has not been established in this group of patients. The treatment in ECMO is complicated since blood is circulated outside the body to achieve oxygenation. This has been shown with other drugs to alter the effective therapeutic dose. The purpose of this study is to monitor the blood levels of Oseltamivir in adults and children during treatment on ECMO. This will enable the effective therapeutic dose to be established for future ECMO patients.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/8

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Further Information Favourable Opinion