Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
112
1 country
1
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 treatment failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 14, 2014
July 1, 2014
3.3 years
August 9, 2011
July 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Absence rate of IFDs assessed by physical examination and serum galactomannan test
Absence of proven, probable, possible invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of Micafungin prophyalxis after HSCT
4 weeks
Secondary Outcomes (2)
Survival rate
100 days
Safety assessed by lab-test and adverse events
4 weeks
Study Arms (1)
Micafungin
EXPERIMENTALInterventions
Eligible patients who provided informed consent form will be administered micafungin at 50 mg/day (1mg/kg/day for patients weighting \<50kg) as 1-h infusion. Infusion of Micafungin will be started on the day -2 of the conditioning course of autologous stem cell transplantation
Eligibility Criteria
You may qualify if:
- Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation
- Under 21 years old, pediatric, adolescent patients.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Chongno-gu, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyoung Jin Kang, M.D, Ph.D
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 16, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 14, 2014
Record last verified: 2014-07