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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841971
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):
Nina Singh, 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

Condition or disease Intervention/treatment Phase
Mycoses Fungemia Central Nervous System Fungal Infections Lung Diseases, Fungal Drug: Anidulafungin Drug: Fluconazole Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
Study Start Date : February 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: anidulafungin
anti-fungal agent
Drug: Anidulafungin
200 mg IV loading dose followed by 100 mg qd for 21 days
Other Name: Eraxis
Active Comparator: Fluconazole
anti-fungal agent
Drug: Fluconazole
400 mg IV for 21 days
Other Name: DIFLUCAN

Primary Outcome Measures :
  1. Frequency of Fungal Infection [ Time Frame: 90 days post enrollment ]

Secondary Outcome Measures :
  1. Need for Additional Antifungal Therapy [ Time Frame: 90 days post enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841971

United States, California
UCLA Medical Cente
Los Angeles, California, United States, 90095
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Nina Singh, MD University of Pittaburgh, VA Pittsburgh Health Systems

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nina Singh, MD, University of Pittsburgh Identifier: NCT00841971     History of Changes
Other Study ID Numbers: PRO08110001
First Posted: February 12, 2009    Key Record Dates
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Communicable Diseases
Lung Diseases
Invasive Fungal Infections
Central Nervous System Fungal Infections
Lung Diseases, Fungal
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Infections
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs