Title
Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipientsRandomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients
Author
Contributor
Michielsen, Peter
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Research group
Laboratory Experimental Medicine and Pediatrics (LEMP)
Publication type
article
Publication
Chicago, Ill.,
Subject
Human medicine
Source (journal)
Clinical infectious diseases. - Chicago, Ill.
Volume/pages
60(2015):7, p. 997-1006
ISSN
1058-4838
ISI
000353714000004
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
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. The full analysis set comprised 344 patients (172 micafungin; 172 standard care). Mean age was 51.2 years; 48.0% had a Model for End-Stage Liver Disease score ≥20. At EOP (mean treatment duration, 17 days), clinical success was 98.6% for micafungin and 99.3% for standard care (Δ standard care micafungin [95% confidence interval], 0.7% [−2.7% to 4.4%]) in the per protocol set and 96.5% and 93.6%, respectively (−2.9% [−8.0% to 1.9%]), in the full analysis set. Incidences of drug-related adverse events for micafungin and standard care were 11.6% and 16.3%, leading to discontinuation in 6.4% and 11.6% of cases, respectively. At EOP, liver function tests were similar but creatinine clearance was higher in micafungin- vs standard caretreated patients. Conclusions. Micafungin was noninferior to standard care as antifungal prophylaxis in liver transplant patients at high risk for IFI. Adverse event profiles and liver function at EOP were similar, although kidney function was better with micafungin.
Full text (open access)
https://repository.uantwerpen.be/docman/irua/6305d5/c94f378c.pdf
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