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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841971
• Other study ID #: PRO08110001
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2009
• Last updated: December 15, 2014
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Anidulafungin
200 mg IV loading dose followed by 100 mg qd for 21 days
• Fluconazole
400 mg IV for 21 days

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	UCLA Medical Cente	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Singh N. Randomized, double-blind trial of anidulafungin versus fluconazole for prophylaxis of invasive fungal infections in high-risk liver transplant recipients. Am J Trans — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Fungal Infection		90 days post enrollment	No
Secondary	Need for Additional Antifungal Therapy		90 days post enrollment	No