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 IFDime 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
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