Status:
COMPLETED
Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Lead Sponsor:
University of Pittsburgh
Conditions:
Mycoses
Fungemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
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 signi...
Eligibility Criteria
Inclusion
- 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
- Hypersensitivity to azole or echinocandin antifungal agents
- receipt of systemic antifungal therapy within 4 weeks prior to transplantation
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00841971
Start Date
February 1 2010
End Date
May 1 2014
Last Update
December 17 2014
Active Locations (6)
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1
UCLA Medical Cente
Los Angeles, California, United States, 90095
2
University of Miami
Miami, Florida, United States, 33136
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213