Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients.

ABSTRACT:

Background

Invasive fungal infection (IFI) following liver transplant is associated with significant morbidity and mortality. Antifungal prophylaxis is rational for liver transplant patients at high IFI risk.

Methods

In this open-label, noninferiority study, patients were randomized 1:1 to receive intravenous micafungin 100 mg or center-specific standard care (fluconazole, liposomal amphotericin B, or caspofungin) posttransplant. The primary endpoint was clinical success (absence of a proven/probable IFI and no need for additional antifungals) at end of prophylaxis (EOP). Noninferiority (10% margin) of micafungin vs standard care was assessed in the per protocol and full analysis sets. Safety assessments included adverse events and liver and kidney function tests.

Results

SUBMITTER: Saliba F 

PROVIDER: S-EPMC4357288 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature