NCT01974375

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.8 years

First QC Date

October 18, 2013

Last Update Submit

October 27, 2013

Conditions

Liver Transplant Recipient

Keywords

Living donorLiver transplantantifungal prevention

Outcome Measures

Primary Outcomes (1)

  • Prevention of invasive fungal disease

    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)

    6 months

Secondary Outcomes (6)

  • no events of proven/probable IFD

    6 months

  • ime to proven/probable IFD

    6 months

  • fungal-free survival

    6 months

  • incidence of superficial mycosis infection and colonization

    6 months

  • saftey by variables

    6 months

  • +1 more secondary outcomes

Study Arms (2)

micafungin

EXPERIMENTAL

micafungin sodium IV (Mycamine®)

Drug: micafungin

Fluconazole

ACTIVE COMPARATOR

Fluconazole IV (use same brand in each hospital)

Drug: Fluconazole

Interventions

micafunginDRUG

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

Also known as: Mycamine
micafungin
FluconazoleDRUG

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

Fluconazole

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 20 years.
  • Undergoing Living Donor Liver Transplantation(LDLT)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

RECRUITING

Related Publications (1)

  • Kang WH, Song GW, Lee SG, Suh KS, Lee KW, Yi NJ, Joh JW, Kwon CHD, Kim JM, Choi DL, Kim JD, Kim MS. A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients. J Gastrointest Surg. 2020 Apr;24(4):832-840. doi: 10.1007/s11605-019-04241-w. Epub 2019 May 7.

    PMID: 31066013DERIVED

MeSH Terms

Interventions

MicafunginFluconazole

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giwon Song, Professor

CONTACT

+82-10-8794-8701drsong71@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 18, 2013

First Posted

November 1, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

KR(1)