Liver Transplant EuropeaN study into Prevention of fungal InfectioN

• Research type

  Research Study

• Full title

  Randomized, Open label, Non-inferiority Study of Micafungin versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients. Phase IIIb Study of Mycamine® (FK463):ISN/Protocol 9463-EC-0001. Subtitle: TENPIN

• IRAS ID

  24830

• Contact name

  Tahir Shah

• Sponsor organisation

  Astellas Pharma Ltd

• Eudract number

  2008-005214-49

• ISRCTN Number

  N/A

• Research summary

  Despite advances in surgical techniques ,anti-rejection drugs and medical management, fungal infections in people receiving liver transplants are a serious clinical problem. The incidence of fungal infections after liver transplantation ranges from 7% to 42%. Death rates in patients with for invasive fungal infections range from 30% to 90%, dependent on the infective organism. Published clinical studies have shown that preventive (prophylactic) antifungal medication reduces the incidence of proven invasive fungal infections and deaths due to Candida albicans ,the most common Candida species.A variety of antifungal prophylactic regimens usinfluonazole or amphotericin B are being used in everyday practice in liver transplant patients. The potential problems associated with the use of these agents does however warrant an evaluation of newer antifungal agents such as the echinocandins.Whilst all three of the currently approved echinocandins (caspofungin, anidulofungin and micafungin) have been tested in clinical trials in the treatment of invasive Candida infections, only micafungin has been studied in clinical trials as antifungal prophylaxis and is currently approved for use as prophylaxis in patients undergoing hematopoietic (blood-forming) stem cell transplantation and patients at risk of neutropenia (low white cell counts). There is limited information available on the use of echinocandins as prophylaxis in patients receiving liver transplants, with no fully-controlled clinical trials published to date. In this study, liver transplant recipients at high risk of invasive fungal infection (eg those with acute liver failure, re-transplantation, renal impairment, extended ICU care, etc) will be randomised to receive either micafungin or the hospital??s normal ??standard care? antifungal prophylaxis treatment (eithefluonazole, liposomal amphoteracin B or caspofungin) for up to 21 days. At the end of the study, clinical success will be assessed by an Independent Data Review Board, based on the presence or absence of invasive fungal disease, any additional antifungal.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/79

• Date of REC Opinion

  11 Jan 2010

• REC opinion

  Further Information Favourable Opinion