Fungal Disease, Neutropenia
Conditions
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.
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 micafungin prophylaxis after Autologous 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.
Interventions
DRUGmicafungin
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
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation 2. Under 21 years old, pediatric, adolescent patients.
Exclusion criteria
1. Aspartate transaminase or alanine transaminase level \> 5 times UNL 2. Bilirubin \> 2.5 times UNL 3. History of allergy, sensitivity, or any serious reaction to an echinocandin 4. Invasive fungal disease at the time of enrolment 5. Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug 6. Positive pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence rate of IFDs assessed by physical examination and serum galactomannan test | 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 100 days | IFD-related mortality |
| Safety assessed by lab-test and adverse events | 4 weeks | Safety profiles |
Countries
South Korea
Contacts
Primary ContactHyoung Jin Kang, M.D, Ph.D
Backup ContactHyery Kim, M.D.
Outcome results
None listed