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)
- Conditions
- Fungal infection.MedDRA version: 9.1Level: LLTClassification code 10042941Term: Systemic fungal infection NOS
- Registration Number
- EUCTR2008-005214-49-BE
- Lead Sponsor
- Astellas Pharma Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 338
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus ‘standard care’ for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, in ‘high risk’ patients undergoing liver transplantation.;Secondary Objective: To assess;<br>•efficacy<br>•safety and tolerability<br>•fungal-free survival<br>• health economic variables<br>of micafungin versus ‘standard care’ in ‘high risk’ subjects undergoing liver transplantation.<br>;Primary end point(s): Clinical success
- Secondary Outcome Measures
Name Time Method