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Completed

NCT Number: NCT00841971

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

The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

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Key information

Conditions

Mycoses Bacterial Infections and Mycoses Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Fungemia Infections Inflammation Invasive Fungal Infections Lung Diseases Lung Diseases, Fungal Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCLA Medical Cente, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anidulafungin

Drug

200 mg IV loading dose followed by 100 mg qd for 21 days

Other names: Eraxis

Fluconazole

Drug

400 mg IV for 21 days

Other names: DIFLUCAN

Primary outcomes

  1. Frequency of Fungal Infection

    Time frame: 90 days post enrollment

Secondary outcomes

  1. Need for Additional Antifungal Therapy

    Time frame: 90 days post enrollment

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 12, 2009
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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