Clinical trial NCT01974375: Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
Official title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Transplant Recipient
Keywords: Living donor
Liver transplant
antifungal prevention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 172
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is Randomized, Open label, Non-inferiority Study of Micafungin versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

After transplant subjects will be randomized to one of the following treatment arms:

* Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)
* Fluconazole 100\~200mg/day, IV care until oral medication becomes possible

Stratification according to centers. Antifungal prophylaxis will be administered once daily for a period of 21 days, or until hospital discharge, whichever occurs first.

This is an open label study; Study center personnel will not be blinded to treatment.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years.
* Undergoing Living Donor Liver Transplantation(LDLT)

Exclusion Criteria:

* Any systemic antifungal therapy (excluding fluconazole or SDD for a maximum of 7 days) within 14 days prior to randomization.
* Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria).
* Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients.
* Reimplantation or orthotopic transplantation patient.

Primary outcomes:
measure: Prevention of invasive fungal disease
timeFrame: 6 months
Secondary outcomes:
measure: no events of proven/probable IFD
timeFrame: 6 months
measure: ime to proven/probable IFD
timeFrame: 6 months
measure: fungal-free survival
timeFrame: 6 months
measure: incidence of superficial mycosis infection and colonization
timeFrame: 6 months
measure: saftey by variables
timeFrame: 6 months
measure: cases of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: SUNG-GYU LEE, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Giwon Song, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University
name: Namjoon Lee, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jaewon Joh, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Dong-Lak Choi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Myung Soo Kim, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.