NCT01974375

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant Recipient

Interventions

Type	Name	Description
DRUG	micafungin	Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)
DRUG	Fluconazole	Fluconazole 100\~200mg/day, IV care until oral medication becomes possible

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2013-11-01
• Last updated: 2013-11-01

Locations

1 site across 1 country: South Korea