Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Neutropenia, Fungal Disease

Intervention / Treatment
-----------------
* Drug: micafungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation Under 21 years old, pediatric, adolescent patients. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micafungin<br> | Drug: micafungin<br>* 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<br>* Other names: Mycamine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | IFD-related mortality | 100 days | 
| Safety assessed by lab-test and adverse events | Safety profiles | 4 weeks |