Phase 4 N=200 Randomized Triple-blind Prevention

Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients

Mycoses · Fungemia · Central Nervous System Fungal Infections · Lung Diseases, Fungal

Bottom Line

View on ClinicalTrials.gov: NCT00841971 ↗

Enrolled (actual)

200

Serious AEs

0.5%

Results posted

Dec 2014

Primary outcome: Primary: Frequency of Fungal Infection — 5; 8 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Anidulafungin (Drug); Fluconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Fungal Infection	5; 8	—
SECONDARY Need for Additional Antifungal Therapy	11; 11	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00841971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.