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

Phase 4

Completed

• Conditions: Central Nervous System Fungal Infections; Mycoses; Fungemia; Lung Diseases, Fungal
• Interventions: Drug: Fluconazole; Drug: Anidulafungin

• Registration Number: NCT00841971
• Lead Sponsor: University of Pittsburgh

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 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.

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2010-02
• Primary Completion: 2013-07
• Study Completion: 2014-05
• Status Verified: 2014-12
• Results First Submitted: 2014-12-08
• Results First Submitted QC: 2014-12-15
• Last Update Submitted: 2014-12-15
• Results First Posted: 2014-12-17
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Liver transplant recipient at increased risk for infection increased risk include any of the following:
• retransplantation
• renal replacement therapy (dialysis),
• post transplant abdominal surgery (within 21days)
• receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding transplant
• ICU care for greater than 48 hours at the time of transplantation
• colonization with Candida sps within 4 weeks of transplantation
• requirement of 15 units or greater of packed red cell transfusions
• Intraoperative time exceeding 6 hours

Exclusion Criteria

• Hypersensitivity to azole or echinocandin antifungal agents
• receipt of systemic antifungal therapy within 4 weeks prior to transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluconazole	Fluconazole	anti-fungal agent
anidulafungin	Anidulafungin	anti-fungal agent

Primary Outcome Measures

Name	Time	Method
Frequency of Fungal Infection	90 days post enrollment

Secondary Outcome Measures

Name	Time	Method
Need for Additional Antifungal Therapy	90 days post enrollment

Trial Locations

Locations (6)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

UCLA Medical Cente; 🇺🇸 Los Angeles, California, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States