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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micafungin | Experimental | micafungin sodium IV (Mycamine®) |
|
| Fluconazole | Active Comparator | Fluconazole IV (use same brand in each hospital) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin | Drug | Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of invasive fungal disease | 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| no events of proven/probable IFD | no events of proven/probable IFD at end of prophylaxis visit and end of study visit | 6 months |
| ime to proven/probable IFD | Time to proven/probable IFD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giwon Song, Professor | Contact | +82-10-8794-8701 | drsong71@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| SUNG-GYU LEE, Professor | Asan Medical Center | Principal Investigator |
| Giwon Song, Professor | Asan Medical Center | Principal Investigator |
| Namjoon Lee, Professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31066013 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Fluconazole | Drug | Fluconazole 100~200mg/day, IV care until oral medication becomes possible |
|
| 6 months |
| fungal-free survival | fungal-free survival et end of study/and long-term follow-up visit | 6 months |
| incidence of superficial mycosis infection and colonization | incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline | 6 months |
| saftey by variables | saftey by variables of viatl sign/physical examination/laboratory test | 6 months |
| cases of adverse events | cases of adverse events | 6 months |
| Seoul National University |
| Principal Investigator |
| Jaewon Joh, Professor | Samsung Medical Center | Principal Investigator |
| Dong-Lak Choi, Professor | Daegu Catholic University Medical Center | Principal Investigator |
| Myung Soo Kim, professor | Severance Hospital | Principal Investigator |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |