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.
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 micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
145
i.v.
Unnamed facility
Busan, South Korea
RECRUITINGUnnamed facility
Daegu, South Korea
RECRUITINGUnnamed facility
Daejeon, South Korea
RECRUITINGAbsence rate of IFDs assessed by physical examination and serum galactomannan test
Time frame: during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis
Survival rate
Time frame: at day 100
Safety assessed by lab-test and adverse events
Time frame: during micafungin prophylaxis therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Goyang, South Korea
RECRUITINGUnnamed facility
Hwasun, South Korea
RECRUITINGUnnamed facility
Seoul, South Korea
RECRUITINGUnnamed facility
Suwon, South Korea
RECRUITING