NCT00841971

Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients

Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Mycoses
• Fungemia
• Central Nervous System Fungal Infections
• Lung Diseases, Fungal

Interventions

Type	Name	Description
DRUG	Anidulafungin	200 mg IV loading dose followed by 100 mg qd for 21 days
DRUG	Fluconazole	400 mg IV for 21 days

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-07-01
• Completion: 2014-05-01
• First posted: 2009-02-12
• Last updated: 2014-12-17
• Results posted: 2014-12-17

Locations

6 sites across 1 country: United States