Liver Transplant European Study Into the Prevention of Fungal Infection

• Status: Completed
• Trial end date: 2012-05-03
• Target enrollment: 0
• Participant gender: All

Summary

Prevention of invasive fungal infection in high risk patients following liver transplant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Amphotericin B; Caspofungin; Echinocandins; Fluconazole; Liposomal amphotericin B; Micafungin

Criteria

Inclusion Criteria:

• Undergoing orthotopic whole or split liver allograft transplantation

• 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

• Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study

Exclusion Criteria:

• Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum of 7 days) within 14 days prior to randomization

• Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria)

• Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients