EUCTR2008-005214-49-GB进行中（未招募）1 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 - TENPIN (Liver Transplant EuropeaN study into the Prevention of fungal InfectioN)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Age >= 18 years.
- •2.Undergoing orthotopic whole or split liver allograft transplantation.
- •3.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-operative renal impairment (defined as creatinine clearance =40 ml/min) or need for renal replacement therapy
- •Post-operative renal impairment (defined as creatinine clearance =40 ml/min) or need for renal replacement therapy within 5 days following liver transplant
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any systemic antifungal therapy (excluding fluconazole or selective digestive decontamination for a maximum of 7 days) within 14 days prior to randomization.
- •2.Evidence of documented (‘proven’ or ‘probable’) or suspected (‘possible’) IFD (according to the EORTC/MSG criteria).
- •3.Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients.
研究者
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