Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | IFD-related mortality | 100 days |
| Safety assessed by lab-test and adverse events | Safety profiles | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyoung Jin Kang, M.D, Ph.D | Contact | 82 2 2072 3304 | kanghj@snu.ac.kr | |
| Hyery Kim, M.D. | Contact | 82 2 2072 0177 | taban@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Hyoung Jin Kang, M.D, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Chongno-gu | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
Not provided
Not provided