Liver Transplant European Study Into the Prevention of Fungal Infection | Completed
Liver Transplant European Study Into the Prevention of Fungal Infection
TENPIN
Trial Source

Health Conditions
  • Liver Transplantation
  • Mycoses
Completed
Recruitment Status
NCT01058174
Primary Trial ID Number
Summary
Prevention of invasive fungal infection in high risk patients following liver transplant.
Primary Outcome Measures
  • 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).; up to 21 days
Secondary Outcome Measures
  • 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
Research Question
  • Prevention of invasive fungal infection in high risk patients following liver transplant.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
Austria; Belgium; Czech Republic; France; Germany; Hungary; Ireland; Italy; Portugal; Romania; Russian Federation; Saudi Arabia; Spain; Sweden; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion 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
Interventions
Drug; micafungin; intravenous infusion; [micafungin]; Drug; fluconazole; intravenous infusion; [standard care]; Drug; liposomal amphotericin B; intravenous infusion; [standard care]; Drug; caspofungin; intravenous infusion; [standard care]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Results Reporting
Sorry, this information is not available
Acronym
TENPIN
Scientific 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
Secondary Trial Identifying Number
2008-005214-49
Website
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=894; https://astellasclinicalstudyresults-staging.azurewebsites.net/hcp/study.aspx?ID=9463-EC-0001
Study Funded By
Astellas Pharma Inc
Funder Type
Sorry, this information is not available
Study Sponsored By
Astellas Pharma Inc
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

26 Jan 2010

Last Updated

05 Jun 2015

Date Record Refreshed on UKCTG

31 Jul 2015