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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Anidulafungin
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anidulafungin<br>anti-fungal agent | Drug: Anidulafungin<br>* 200 mg IV loading dose followed by 100 mg qd for 21 days<br>* Other names: Eraxis;|
| Active Comparator: Fluconazole<br>anti-fungal agent | Drug: Fluconazole<br>* 400 mg IV for 21 days<br>* Other names: DIFLUCAN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Fungal Infection |  | 90 days post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Additional Antifungal Therapy |  | 90 days post enrollment |