Liver Transplant Recipient
Conditions
Keywords
Living donor, Liver transplant, antifungal 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.
Interventions
DRUGmicafungin
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)
DRUGFluconazole
Fluconazole 100\ 200mg/day, IV care until oral medication becomes possible
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of invasive fungal disease | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ime to proven/probable IFD | 6 months | Time to proven/probable IFD |
| fungal-free survival | 6 months | fungal-free survival et end of study/and long-term follow-up visit |
| no events of proven/probable IFD | 6 months | no events of proven/probable IFD at end of prophylaxis visit and end of study visit |
| saftey by variables | 6 months | saftey by variables of viatl sign/physical examination/laboratory test |
| cases of adverse events | 6 months | cases of adverse events |
| incidence of superficial mycosis infection and colonization | 6 months | incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline |
Countries
South Korea
Contacts
Primary ContactGiwon Song, Professor
Outcome results
None listed