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

Asan Medical Center

Status and phase: Unknown; Phase 3

Conditions: Liver Transplant Recipient

Treatments: Drug: micafungin; Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01974375

MYC-LT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

micafungin

Experimental group

Description:

micafungin sodium IV (Mycamine®)

Treatment:

Drug: micafungin

Fluconazole

Active Comparator group

Description:

Fluconazole IV (use same brand in each hospital)

Treatment:

Drug: Fluconazole