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.


Invasive fungal infections (IFIs) are a common complication in liver transplant recipients. There are no previous randomized trials of an echinocandin for the prevention of IFIs in solid organ transplant recipients. In a randomized, double-blind trial conducted at University-affiliated transplant centers, 200 high-risk liver transplant recipients (100 patients per group) received either anidulafungin or fluconazole for antifungal prophylaxis. Randomization was stratified by Model for End-Stage Liver Disease score ≥30 and receipt of a pretransplant antifungal agent. The primary end point was IFI in a modified intent-to-treat analysis. The overall incidence of IFI was similar for the anidulafungin (5.1%) and the fluconazole groups (8.0%) (OR 0.61, 95% CI 0.19-1.94, p = 0.40). However, anidulafungin prophylaxis was associated with less Aspergillus colonization or infection (3% vs. 9%, p = 0.08), lower breakthrough IFIs among patients who had received pretransplant fluconazole (0% vs. 27%, p = 0.07), and fewer cases of antifungal resistance (no cases vs. 5 cases). Both drugs were well-tolerated. Graft rejection, fungal-free survival, and mortality were similar for both groups. Thus, anidulafungin and fluconazole have similar efficacy for antifungal prophylaxis in most liver transplant recipients. Anidulafungin may be beneficial if the patient has an increased risk for Aspergillus infection or received fluconazole before transplantation.

Trial registration: ClinicalTrials.gov NCT00841971.

Keywords: Clinical research/practice; fungal; infection and infectious agents; infectious disease.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anidulafungin
  • Antibiotic Prophylaxis*
  • Antifungal Agents / therapeutic use
  • Double-Blind Method
  • Echinocandins / therapeutic use*
  • Female
  • Fluconazole / therapeutic use*
  • Follow-Up Studies
  • Graft Rejection / epidemiology*
  • Graft Rejection / microbiology
  • Graft Rejection / mortality
  • Graft Survival
  • Humans
  • Immunocompromised Host
  • Incidence
  • Liver Diseases / complications*
  • Liver Diseases / microbiology
  • Liver Diseases / surgery
  • Liver Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Mycoses / epidemiology
  • Mycoses / microbiology
  • Mycoses / prevention & control*
  • Postoperative Complications
  • Prognosis
  • Risk Factors
  • Survival Rate
  • Transplant Recipients
  • United States / epidemiology
  • Young Adult


  • Antifungal Agents
  • Echinocandins
  • Fluconazole
  • Anidulafungin

Associated data

  • ClinicalTrials.gov/NCT00841971