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

NCT01974375 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2013-11-01

No results posted yet for this study

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.

Conditions

  • Liver Transplant Recipient

Interventions

DRUG

micafungin

Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)

DRUG

Fluconazole

Fluconazole 100\~200mg/day, IV care until oral medication becomes possible

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • SUNG-GYU LEE, Professor · Asan Medical Center

  • Giwon Song, Professor · Asan Medical Center

  • Namjoon Lee, Professor · Seoul National University

  • Jaewon Joh, Professor · Samsung Medical Center

  • Dong-Lak Choi, Professor · Daegu Catholic University Medical Center

  • Myung Soo Kim, professor · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01974375 on ClinicalTrials.gov