NCT01058174已完成3 期
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 主要终点
- 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
研究概览
简要总结
Prevention of invasive fungal infection in high risk patients following liver transplant.
详细描述
After receiving liver transplant, subjects will be randomized to one of the two treatment arms.
Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.
Additionally, mortality data will be collected at the Long-term Follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing orthotopic whole or split liver allograft transplantation
- •Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:
- •Re-transplantation
- •Acute liver failure
- •Pre- or post-operative renal impairment (defined as creatinine clearance ≤40 ml/min) or need for renal replacement therapy
- •Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver transplant
- •Re-operation (abdominal surgery) within 5 days of liver transplant
- •Presence of choledocojejunostomy
- •Perioperative colonization with fungi, defined as two or more positive clinical site surveillance cultures for Candida spp., obtained within 96 hours before or after liver transplant
- •Need for prolonged mechanical ventilation for greater than 48 hours following liver transplant
- •Transfusion intraoperatively of 20 or more units of cellular blood products
- •Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study
排除标准
- •Any systemic antifungal therapy (excluding fluconazole or oral nystatin 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
研究组 & 干预措施
micafungin
Experimental
intravenous infusion
干预措施: micafungin (Drug)
standard care
Active Comparator
intravenous infusion
干预措施: fluconazole (Drug)
standard care
Active Comparator
intravenous infusion
干预措施: liposomal amphotericin B (Drug)
standard care
Active Comparator
intravenous infusion
干预措施: caspofungin (Drug)
结局指标
主要结局
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
时间窗: up to 21 days
次要结局
- Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator(up to 21 days & 3 months)
- Fungal free survival at the End of Study and at the end of Long-term Follow-up(3 months & 6 months)
- Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB(3 months)
- Time to 'proven' or 'probable' IFD(up to 3 months)
- Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline(up to 21 days)
研究者
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