A Phase 3 interventional study of micafungin and Fluconazole in Liver Transplant Recipient, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-11-01.
Sponsored by Asan Medical Center · Phase 3, Interventional, and Prevention
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.
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:
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.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's planned enrollment of 172 is above the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
micafungin sodium IV (Mycamine®)
Drug: micafungin
Fluconazole IV (use same brand in each hospital)
Drug: Fluconazole
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing \<40 kg)
Also known as: Mycamine
Fluconazole 100\~200mg/day, IV care until oral medication becomes possible
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)
Time frame: 6 months
no events of proven/probable IFD
no events of proven/probable IFD at end of prophylaxis visit and end of study visit
Time frame: 6 months
ime to proven/probable IFD
Time to proven/probable IFD
Time frame: 6 months
fungal-free survival
fungal-free survival et end of study/and long-term follow-up visit
Time frame: 6 months
incidence of superficial mycosis infection and colonization
incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline
Time frame: 6 months
saftey by variables
saftey by variables of viatl sign/physical examination/laboratory test
Time frame: 6 months
cases of adverse events
cases of adverse events
Time frame: 6 months
This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asan Medical Center