Liver Transplantation Clinical Trial
— TENPINOfficial title:
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
Verified date | March 2019 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prevention of invasive fungal infection in high risk patients following liver transplant.
Status | Completed |
Enrollment | 350 |
Est. completion date | May 3, 2012 |
Est. primary completion date | May 3, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Austria, Belgium, France, Germany, Hungary, Ireland, Italy, Portugal, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). | up to 21 days | ||
Secondary | Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB | 3 months | ||
Secondary | 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 | ||
Secondary | Time to 'proven' or 'probable' IFD | up to 3 months | ||
Secondary | Fungal free survival at the End of Study and at the end of Long-term Follow-up | 3 months & 6 months | ||
Secondary | Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline | up to 21 days |
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