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

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Transplant Recipient

Intervention: micafungin (Drug); Fluconazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
SUNG-GYU LEE, Professor, Principal Investigator, Affiliation: Asan Medical Center
Giwon Song, Professor, Principal Investigator, Affiliation: Asan Medical Center
Namjoon Lee, Professor, Principal Investigator, Affiliation: Seoul National University
Jaewon Joh, Professor, Principal Investigator, Affiliation: Samsung Medical Center
Dong-Lak Choi, Professor, Principal Investigator, Affiliation: Daegu Catholic University Medical Center
Myung Soo Kim, professor, Principal Investigator, Affiliation: Severance Hospital

Overall contact:
Giwon Song, Professor, Phone: +82-10-8794-8701, Email: drsong71@hotmail.com

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 Details

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

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

Primary outcome: Prevention of invasive fungal disease

Secondary outcome:

no events of proven/probable IFD

ime to proven/probable IFD

fungal-free survival

incidence of superficial mycosis infection and colonization

saftey by variables

cases of adverse events

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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Giwon Song, Professor, Phone: +82-10-8794-8701, Email: drsong71@hotmail.com

Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Giwon Song, Professor, Phone: +82-10-8794-8701, Email: drsong71@hotmail.com
Additional Information

Starting date: August 2012
Last updated: October 27, 2013

Page last updated: August 23, 2015

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