Clinical Trial: Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
Brief Summary: The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients
Detailed Summary:
A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.
Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.
Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.
Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.
The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.
Sponsor: University of Pittsburgh
Current Primary Outcome: Frequency of Fungal Infection [ Time Frame: 90 days post enrollment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Need for Additional Antifungal Therapy [ Time Frame: 90 days post enrollment ]
Original Secondary Outcome: Same as current
Information By: University of Pittsburgh
Dates:
Date Received: February 11, 2009
Date Started: February 2010
Date Completion:
Last Updated: December 15, 2014
Last Verified: December 2014
