This study investigates the efficacy of micafungin in comparison to other treatments in liver-transplanted patients.
- Conditions
- Fungal infection.MedDRA version: 14.0Level: LLTClassification code 10042941Term: Systemic fungal infection NOSSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2008-005214-49-DE
- 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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38
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;Timepoint(s) of evaluation of this end point: At end of prophylaxis
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Absence of a ‘proven’ or ‘probable’ IFD at the End of Study as assessed by the IDRB<br>•Absence of ‘proven’ or ‘probable’ IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator<br>•Time to ‘proven’ or ‘probable’ IFD<br>•Fungal free survival at the End of Study and at the end of Long-term Follow-up <br>•Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline<br>;Timepoint(s) of evaluation of this end point: see above