Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Primary Purpose
Mycoses, Fungemia, Central Nervous System Fungal Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anidulafungin
Fluconazole
Sponsored by
About this trial
This is an interventional prevention trial for Mycoses
Eligibility 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
Sites / Locations
- UCLA Medical Cente
- University of Miami
- University of Michigan
- University of Pittsburgh
- University of Washington Medical Center
- University of Wisconsin - Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
anidulafungin
Fluconazole
Arm Description
anti-fungal agent
anti-fungal agent
Outcomes
Primary Outcome Measures
Frequency of Fungal Infection
Secondary Outcome Measures
Need for Additional Antifungal Therapy
Full Information
NCT ID
NCT00841971
First Posted
February 11, 2009
Last Updated
December 15, 2014
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00841971
Brief Title
Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Official Title
Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses, Fungemia, Central Nervous System Fungal Infections, Lung Diseases, Fungal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anidulafungin
Arm Type
Experimental
Arm Description
anti-fungal agent
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
anti-fungal agent
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Other Intervention Name(s)
Eraxis
Intervention Description
200 mg IV loading dose followed by 100 mg qd for 21 days
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
DIFLUCAN
Intervention Description
400 mg IV for 21 days
Primary Outcome Measure Information:
Title
Frequency of Fungal Infection
Time Frame
90 days post enrollment
Secondary Outcome Measure Information:
Title
Need for Additional Antifungal Therapy
Time Frame
90 days post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Singh, MD
Organizational Affiliation
University of Pittaburgh, VA Pittsburgh Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Cente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25376267
Citation
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.
Results Reference
result
PubMed Identifier
26050015
Citation
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.
Results Reference
derived
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Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
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