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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

Conditions
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Liver Transplant Recipient

Intervention / Treatment
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* Drug: micafungin
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micafungin<br>micafungin sodium IV (Mycamine®) | Drug: micafungin<br>* Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)<br>* Other names: Mycamine;|
| Active Comparator: Fluconazole<br>Fluconazole IV (use same brand in each hospital) | Drug: Fluconazole<br>* Fluconazole 100 200mg/day, IV care until oral medication becomes possible<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no events of proven/probable IFD | no events of proven/probable IFD at end of prophylaxis visit and end of study visit | 6 months | 
| ime to proven/probable IFD | Time to proven/probable IFD | 6 months | 
| fungal-free survival | fungal-free survival et end of study/and long-term follow-up visit | 6 months | 
| incidence of superficial mycosis infection and colonization | incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline | 6 months | 
| saftey by variables | saftey by variables of viatl sign/physical examination/laboratory test | 6 months | 
| cases of adverse events | cases of adverse events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Living donor, Liver transplant, antifungal prevention