Fungal infection. MedDRA version: 9.1 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS
Conditions
Interventions
Trade Name: Mycamine
Product Name: Micafungin
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Cancidas
Product Name: Caspofungin
Pharmaceutical Form: Powder for concentrate for solu
Sponsors
Astellas Pharma Europe Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; • efficacy • safety and tolerability • fungal-free survival • health economic variables of micafungin versus ‘standard care’ in ‘high risk’ subjects undergoing liver transplantation. ;Primary end point(s): Clinical success | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed