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

Liver Transplant Recipient Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplant Recipient
• Mycoses

• NCT number: NCT01974375
• Study type: Interventional
• Source: Asan Medical Center
• Contact: Giwon Song, Professor
• Phone: +82-10-8794-8701
• Email: drsong71@hotmail.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2012
• Completion date: December 2014