Liver Transplant European Study Into the Prevention of Fungal Infection

Liver Transplantation Clinical Trial

— TENPIN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058174
• Other study ID #: 9463-EC-0001
• Secondary ID: 2008-005214-49
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2009
• Est. completion date: May 3, 2012

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Liver Transplantation
• Mycoses

Intervention

Drug:
• micafungin
intravenous infusion
• fluconazole
intravenous infusion
• liposomal amphotericin B
intravenous infusion
• caspofungin
intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Hungary,  Ireland,  Italy,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Spain,  Sweden,  United Kingdom, 

Outcome

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

External Links

•   Link to results on Astellas Clinical Study Results website