Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
试验速览
- 阶段
- 3 期
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Prevention of invasive fungal disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years.
- •Undergoing Living Donor Liver Transplantation(LDLT)
排除标准
- •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.
研究组 & 干预措施
micafungin
micafungin sodium IV (Mycamine®)
干预措施: micafungin (Drug)
Fluconazole
Fluconazole IV (use same brand in each hospital)
干预措施: Fluconazole (Drug)
结局指标
主要结局
Prevention of invasive fungal disease
时间窗: 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)
次要结局
- ime to proven/probable IFD(6 months)
- no events of proven/probable IFD(6 months)
- fungal-free survival(6 months)
- saftey by variables(6 months)
- incidence of superficial mycosis infection and colonization(6 months)
- cases of adverse events(6 months)