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

Liver Transplant Recipient Clinical Trial

— KOPIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974375
• Other study ID #: MYC-LT-01
• Status: Recruiting
• Phase: Phase 3
• First received: October 18, 2013
• Last updated: October 27, 2013
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Asan Medical Center
• Contact: Giwon Song, Professor
• Phone: +82-10-8794-8701
• Email: drsong71[@]hotmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplant Recipient
• Mycoses

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	no events of proven/probable IFD	no events of proven/probable IFD at end of prophylaxis visit and end of study visit	6 months	No
Secondary	ime to proven/probable IFD	Time to proven/probable IFD	6 months	No
Secondary	fungal-free survival	fungal-free survival et end of study/and long-term follow-up visit	6 months	No
Secondary	incidence of superficial mycosis infection and colonization	incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline	6 months	No
Secondary	saftey by variables	saftey by variables of viatl sign/physical examination/laboratory test	6 months	Yes
Secondary	cases of adverse events	cases of adverse events	6 months	Yes