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

December 15, 2014 updated by: Nina Singh, University of Pittsburgh

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

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

Study Overview

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

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Cente
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anidulafungin
anti-fungal agent
200 mg IV loading dose followed by 100 mg qd for 21 days
Other Names:
  • Eraxis
Active Comparator: Fluconazole
anti-fungal agent
400 mg IV for 21 days
Other Names:
  • DIFLUCAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Fungal Infection
Time Frame: 90 days post enrollment
90 days post enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for Additional Antifungal Therapy
Time Frame: 90 days post enrollment
90 days post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nina Singh, MD, University of Pittaburgh, VA Pittsburgh Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mycoses

Clinical Trials on Anidulafungin

3
Subscribe