Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
NCT ID: NCT00841971
Last Updated: 2014-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2010-02-28
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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anidulafungin
anti-fungal agent
Anidulafungin
200 mg IV loading dose followed by 100 mg qd for 21 days
Fluconazole
anti-fungal agent
Fluconazole
400 mg IV for 21 days
Interventions
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Anidulafungin
200 mg IV loading dose followed by 100 mg qd for 21 days
Fluconazole
400 mg IV for 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* receipt of systemic antifungal therapy within 4 weeks prior to transplantation
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Nina Singh
MD
Principal Investigators
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Nina Singh, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittaburgh, VA Pittsburgh Health Systems
Locations
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UCLA Medical Cente
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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PRO08110001
Identifier Type: -
Identifier Source: org_study_id