Liver Transplantation, Mycoses
Conditions
Keywords
Prophylaxis, Liver transplantation, Invasive Fungal Infection, Micafungin, Prevention, Mycoses
Brief summary
Prevention of invasive fungal infection in high risk patients following liver transplant.
Detailed description
After receiving liver transplant, subjects will be randomized to one of the two treatment arms. Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first. Additionally, mortality data will be collected at the Long-term Follow-up.
Interventions
DRUGmicafungin
intravenous infusion
DRUGfluconazole
intravenous infusion
DRUGliposomal amphotericin B
intravenous infusion
DRUGcaspofungin
intravenous infusion
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). | up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB | 3 months |
| Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator | up to 21 days & 3 months |
| Time to 'proven' or 'probable' IFD | up to 3 months |
| Fungal free survival at the End of Study and at the end of Long-term Follow-up | 3 months & 6 months |
| Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline | up to 21 days |
Countries
Austria, Belgium, France, Germany, Hungary, Ireland, Italy, Portugal, Romania, Russia, Saudi Arabia, Spain, Sweden, United Kingdom
Outcome results
None listed