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

Phase 3

• Conditions: Liver Transplant Recipient
• Interventions: Drug: micafungin; Drug: Fluconazole

• Registration Number: NCT01974375
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-27
• Last Update Submitted: 2013-10-27
• Study First Posted: 2013-11-01
• Last Update Posted: 2013-11-01
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micafungin	micafungin	micafungin sodium IV (Mycamine®)
Fluconazole	Fluconazole	Fluconazole IV (use same brand in each hospital)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of