Clinical trial NCT00841971: Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Official title: Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mycoses
Fungemia
Central Nervous System Fungal Infections
Lung Diseases, Fungal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Fungal Infection
timeFrame: 90 days post enrollment
Secondary outcomes:
measure: Need for Additional Antifungal Therapy
timeFrame: 90 days post enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Cente
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Pittaburgh, VA Pittsburgh Health Systems
name: Nina Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Transplant. 2014 Dec;14(12):2758-64. doi: 10.1111/ajt.12963. Epub 2014 Nov 6.
citation: Singh N, Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Wagener MM, Wheat LJ. Performance Characteristics of Galactomannan and beta-d-Glucan in High-Risk Liver Transplant Recipients. Transplantation. 2015 Dec;99(12):2543-50. doi: 10.1097/TP.0000000000000763.