Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

• Research type

  Research Study

• Full title

  A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients

• IRAS ID

  98796

• Contact name

  Anna Reed

• Sponsor organisation

  MSD

• Eudract number

  2012-003140-68

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Fungal infection is a major cause of morbidity and mortality (around 60%) following lung transplantation. Antifungal agents called triazoles are commonly used early post-transplant as a preventative measure (prophylactically) but, their use can be complicated by side effects and resistance. Posaconazole is a triazole that has a broad spectrum of antifungal activity, a low incidence of side effects, has more consistent availability of the drug in the body and a low incidence of resistance but, is predominantly used as second line treatment. The reason for second line use may be the minimal data available on the efficacy and safety of posaconazole in the lung transplant population. Posaconazole has been shown to prevent invasive fungal infections in high risk haematological patients more effectively than alternative prophylactic therapies. No data exist on plasma and alveolar compartment posaconazole levels following lung transplant. In addition, those undergoing transplant for cystic fibrosis may differ from those undergoing transplant for other indications because CF patients having problems absorbing fat. This study will provide new data on how this drug behaves in cystic fibrosis and non cystic fibrosis patients who undergo lung transplantation. It will also evaluate outcomes in these patients. Merck Sharp & Dohme Corp. will be sponsoring and funding the study which will be conducted at Harefield Hospital. The study will last approximately 18 months, include 40 patients (20 CF and 20 non-CF) and each patient will be on study for approximately 13 weeks. All patients will be treated as per the hospital standard of care, including the use of posaconazole as prophylactic antifungal treatment. Additional blood samples will be taken as part of the study to measure levels of posaconazole.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1356

• Date of REC Opinion

  29 Oct 2012

• REC opinion

  Further Information Favourable Opinion