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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Giwon Song, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01974375
First received: October 18, 2013
Last updated: October 27, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Liver Transplant Recipient
Drug: micafungin
Drug: Fluconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Prevention of invasive fungal disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

    'Clinical success' at the End of Prophylaxis as assessed by the investigator.

    Absence of a 'proven' or 'probable' IFD AND No initiation of antifungal treatment (additional antifungal medication or increase in the dose of the study drug due to lack of efficacy)



Secondary Outcome Measures:
  • no events of proven/probable IFD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    no events of proven/probable IFD at end of prophylaxis visit and end of study visit

  • ime to proven/probable IFD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Time to proven/probable IFD

  • fungal-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    fungal-free survival et end of study/and long-term follow-up visit

  • incidence of superficial mycosis infection and colonization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline

  • saftey by variables [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    saftey by variables of viatl sign/physical examination/laboratory test

  • cases of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    cases of adverse events


Estimated Enrollment: 172
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micafungin
micafungin sodium IV (Mycamine®)
Drug: micafungin
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
Other Name: Mycamine
Active Comparator: Fluconazole
Fluconazole IV (use same brand in each hospital)
Drug: Fluconazole
Fluconazole 100~200mg/day, IV care until oral medication becomes possible
Other Name: Fluconazole

Detailed Description:

This is Randomized, Open label, Non-inferiority Study of Micafungin versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

After transplant subjects will be randomized to one of the following treatment arms:

  • Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
  • Fluconazole 100~200mg/day, IV care until oral medication becomes possible

Stratification according to centers. Antifungal prophylaxis will be administered once daily for a period of 21 days, or until hospital discharge, whichever occurs first.

This is an open label study; Study center personnel will not be blinded to treatment.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974375

Contacts
Contact: Giwon Song, Professor +82-10-8794-8701 drsong71@hotmail.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Giwon Song, Professor    +82-10-8794-8701    drsong71@hotmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: SUNG-GYU LEE, Professor Asan Medical Center
Principal Investigator: Giwon Song, Professor Asan Medical Center
Principal Investigator: Namjoon Lee, Professor Seoul National University
Principal Investigator: Jaewon Joh, Professor Samsung Medical Center
Principal Investigator: Dong-Lak Choi, Professor Daegu Catholic University Medical Center
Principal Investigator: Myung Soo Kim, professor Severance Hospital
  More Information

No publications provided

Responsible Party: Giwon Song, Dr., Asan Medical Center
ClinicalTrials.gov Identifier: NCT01974375     History of Changes
Other Study ID Numbers: MYC-LT-01
Study First Received: October 18, 2013
Last Updated: October 27, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Asan Medical Center:
Living donor
Liver transplant
antifungal prevention

Additional relevant MeSH terms:
Mycoses
Fluconazole
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014