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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
172
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
Asan Medical Center
Seoul, Seoul, South Korea
RECRUITINGPrevention of invasive fungal disease
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. 'Clinical success' at the End of Prophylaxis as assessed by the investigator. Absence of a 'proven' or 'probable' IFD AND No initiation of antifungal treatment (additional antifungal medication or increase in the dose of the study drug due to lack of efficacy)
Time frame: 6 months
no events of proven/probable IFD
no events of proven/probable IFD at end of prophylaxis visit and end of study visit
Time frame: 6 months
ime to proven/probable IFD
Time to proven/probable IFD
Time frame: 6 months
fungal-free survival
fungal-free survival et end of study/and long-term follow-up visit
Time frame: 6 months
incidence of superficial mycosis infection and colonization
incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline
Time frame: 6 months
saftey by variables
saftey by variables of viatl sign/physical examination/laboratory test
Time frame: 6 months
cases of adverse events
cases of adverse events
Time frame: 6 months
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