Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

Summary

The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.

Timeline

Start

2012-08

Primary completion

2014-06

Completion

2014-12

Outcome

Met primary endpoint

paper 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 PMID 31066013 ↗

paper the lower bound for the 90% CI exceeded - 10% PMID 31066013 ↗

Publications

• Kang WH, Song GW, Lee SG, Suh KS, Lee KW, Yi NJ, Joh JW, Kwon CHD, Kim JM, Choi DL, Kim JD, Kim MS. A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients. J Gastrointest Surg. 2020 Apr;24(4):832-840. doi: 10.1007/s11605-019-04241-w. Epub 2019 May 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluconazole	Small molecule	100 mg	Intravenous
Comparator	Fluconazole	Small molecule	200 mg	Intravenous
Subject	Micafungin	Peptide	2 mg/kg	Intravenous
Subject	Micafungin	Peptide	100 mg	Intravenous

Indications

No indication recorded.