Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
NCT ID: NCT01974375
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
172 participants
INTERVENTIONAL
2012-08-31
2014-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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micafungin
micafungin sodium IV (Mycamine®)
micafungin
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)
Fluconazole
Fluconazole IV (use same brand in each hospital)
Fluconazole
Fluconazole 100\~200mg/day, IV care until oral medication becomes possible
Interventions
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micafungin
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)
Fluconazole
Fluconazole 100\~200mg/day, IV care until oral medication becomes possible
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing Living Donor Liver Transplantation(LDLT)
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Giwon Song
Dr.
Principal Investigators
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SUNG-GYU LEE, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Giwon Song, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Namjoon Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University
Jaewon Joh, Professor
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Dong-Lak Choi, Professor
Role: PRINCIPAL_INVESTIGATOR
Daegu Catholic University Medical Center
Myung Soo Kim, professor
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Asan Medical Center
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Giwon Song, Professor
Role: primary
References
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Kang WH, Song GW, Lee SG, Suh KS, Lee KW, Yi NJ, Joh JW, Kwon CHD, Kim JM, Choi DL, Kim JD, Kim MS. A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients. J Gastrointest Surg. 2020 Apr;24(4):832-840. doi: 10.1007/s11605-019-04241-w. Epub 2019 May 7.
Other Identifiers
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MYC-LT-01
Identifier Type: -
Identifier Source: org_study_id