Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)

Astellas

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation; Mycoses

Treatments: Drug: fluconazole; Drug: micafungin; Drug: caspofungin; Drug: liposomal amphotericin B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01058174

2008-005214-49 (EudraCT Number)

9463-EC-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

micafungin

Experimental group

Description:

intravenous infusion

Treatment:

Drug: micafungin

standard care

Active Comparator group

Description:

intravenous infusion

Treatment:

Drug: caspofungin

Drug: liposomal amphotericin B

Drug: fluconazole