Mycoses Clinical Trial
Official title:
Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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