A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients

Woo Hyoung Kang, Gi Won Song, Sung Gyu Lee, Kyung Suk Suh, Kwang Woong Lee, Nam Joon Yi, Jae Won Joh, Choon Hyuck David Kwon, Jong Man Kim, Dong Lak Choi, Joo Dong Kim, Myoung Soo Kim

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Abstract

Background: Although invasive fungal infections (IFIs) contribute to substantial morbidity and mortality in liver transplant recipients, only a few randomized studies analyzed the results of antifungal prophylaxis with echinocandins. The aim of this open-label, non-inferiority study was to evaluate the efficacy and safety of micafungin in the prophylaxis of IFIs in living-donor liver transplantation recipients (LDLTRs), with fluconazole as the comparator. Methods: LDLTRs (N = 172) from five centers were randomized 1:1 to receive intravenous micafungin 100 mg/day or fluconazole 100~200 mg/day (intravenous or oral). A non-inferiority of micafungin was tested against fluconazole. Results: The per-protocol set included 144 patients without major clinical trial protocol violations: 69 from the micafungin group and 75 from the fluconazole group. Mean age of the study patients was 54.2 years and mean model for end-stage liver disease (MELD) score amounted to 16.5. Clinical success rates in the micafungin and fluconazole groups were 95.65% and 96.10%, respectively (difference: − 0.45%; 90% confidence interval [CI]: − 6.93%, 5.59%), which demonstrated micafungin’s non-inferiority (the lower bound for the 90% CI exceeded − 10%). The study groups did not differ significantly in terms of the secondary efficacy endpoints: absence of IFIs at the end of the prophylaxis and the end of the study, time to proven IFI, fungal-free survival, and adverse reactions. A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved. Conclusion: Micafungin can be used as an alternative to fluconazole in the prevention of IFIs in LDLTRs. Clinical Trials Registration: NCT01974375.

Original languageEnglish
Pages (from-to)832-840
Number of pages9
JournalJournal of Gastrointestinal Surgery
Volume24
Issue number4
DOIs
StatePublished - 1 Apr 2020

Keywords

  • Fluconazole
  • Living donor liver transplantation
  • Micafungin
  • Prophylaxis of invasive fungal infection

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