Status:
UNKNOWN
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Seoul National University Hospital
Conditions:
Neutropenia
Fungal Disease
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatmen...
Detailed Description
The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of mic...
Eligibility Criteria
Inclusion
- Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation
- Under 21 years old, pediatric, adolescent patients.
Exclusion
- Aspartate transaminase or alanine transaminase level \> 5 times UNL
- Bilirubin \> 2.5 times UNL
- History of allergy, sensitivity, or any serious reaction to an echinocandin
- Invasive fungal disease at the time of enrolment
- Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
- Positive pregnancy test
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01417169
Start Date
August 1 2011
End Date
December 1 2014
Last Update
July 14 2014
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Chongno-gu, South Korea