Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses; Fungemia; Central Nervous System Fungal Infections; Lung Diseases, Fungal
Intervention: Anidulafungin (Drug); Fluconazole (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Nina Singh, MD, Principal Investigator, Affiliation: University of Pittaburgh, VA Pittsburgh Health Systems
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
Clinical Details
Official title: Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients: a Randomized, Double-Blind Trial
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Frequency of fungal infection
Secondary outcome: Need for additional antifungal therapy
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2009
Ending date: December 2012
Last updated: February 11, 2009
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