Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neutropenia, Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease

Intervention / Treatment
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* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will receive allogeneic hematopoietic stem cell transplantation 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
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Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSCT<br> | Drug: Micafungin<br>* i.v.<br>* Other names: Fungard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence rate of IFDs assessed by physical examination and serum galactomannan test |  | during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | at day 100 | 
| Safety assessed by lab-test and adverse events |  | during micafungin prophylaxis therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, adolescent, micafungin