Randomized, Open label, Non-inferiority Study of Micafungin versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients - TENPI

ASTELLAS PHARMA0 个研究点目标入组 338 人开始时间: 2009年10月9日最近更新: 2012年8月28日

适应症

试验速览

暂无简介。

•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- 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
•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

•1. Any systemic antifungal therapy (excluding fluconazole or oral nystatin 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.

发起方