Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients - Full Text View

Sponsor:	University of Pittsburgh
Information provided by (Responsible Party):	Nina Singh, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00841971

Purpose

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	Intervention	Phase
Mycoses Fungemia Central Nervous System Fungal Infections Lung Diseases, Fungal	Drug: Anidulafungin Drug: Fluconazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Liver Transplantation Molds

Drug Information available for: Fluconazole Anidulafungin

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Frequency of fungal infection [ Time Frame: 90 days post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Need for additional antifungal therapy [ Time Frame: 90 days post enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: anidula	Drug: Anidulafungin 200 mg IV loading dose followed by 100 mg qd for 21 days
Active Comparator: Flu anti-fungal agent	Drug: Fluconazole 400 mg IV for 21 days Other Name: DIFLUCAN

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841971

Locations

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

Investigators

Principal Investigator:

Nina Singh, MD

University of Pittaburgh, VA Pittsburgh Health Systems

More Information

No publications provided

Responsible Party:	Nina Singh, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00841971 History of Changes
Other Study ID Numbers:	PRO08110001
Study First Received:	February 11, 2009
Last Updated:	November 14, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Lung Diseases
Lung Diseases, Fungal
Mycoses
Fungemia
Central Nervous System Fungal Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Central Nervous System Infections

Central Nervous System Diseases
Nervous System Diseases
Fluconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012