Overview

Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

Status:
Unknown status

Trial end date:
2014-12-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Asan Medical Center

Treatments:

Echinocandins
Fluconazole
Micafungin

Criteria

Inclusion Criteria:

- Age > 20 years.

- Undergoing Living Donor Liver Transplantation(LDLT)

Exclusion Criteria:

- Any systemic antifungal therapy (excluding fluconazole or SDD 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.

- Reimplantation or orthotopic transplantation patient.