- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841971
Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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California
-
Los Angeles, California, United States, 90095
- UCLA Medical Cente
-
-
Florida
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Miami, Florida, United States, 33136
- University of Miami
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin - Madison
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Active Comparator: Fluconazole
anti-fungal agent
|
400 mg IV for 21 days
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Nina Singh, MD, University of Pittaburgh, VA Pittsburgh Health Systems
Publications and helpful links
General Publications
- Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Singh N. Randomized, double-blind trial of anidulafungin versus fluconazole for prophylaxis of invasive fungal infections in high-risk liver transplant recipients. Am J Transplant. 2014 Dec;14(12):2758-64. doi: 10.1111/ajt.12963. Epub 2014 Nov 6.
- Singh N, Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Wagener MM, Wheat LJ. Performance Characteristics of Galactomannan and beta-d-Glucan in High-Risk Liver Transplant Recipients. Transplantation. 2015 Dec;99(12):2543-50. doi: 10.1097/TP.0000000000000763.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Central Nervous System Infections
- Bacterial Infections and Mycoses
- Sepsis
- Invasive Fungal Infections
- Lung Diseases
- Infections
- Communicable Diseases
- Mycoses
- Fungemia
- Lung Diseases, Fungal
- Central Nervous System Fungal Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Anidulafungin
- Fluconazole
Other Study ID Numbers
- PRO08110001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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