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

Phase 4

• Conditions: Neutropenia; Hematopoietic Stem Cell Transplantation; Invasive Fungal Disease
• Interventions: Drug: Micafungin

• Registration Number: NCT01135589
• Lead Sponsor: Asan Medical Center

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 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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-25
• Status Verified: 2010-06
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-28
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSCT	Micafungin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Survival rate	at day 100
Safety assessed by lab-test and adverse events	during micafungin prophylaxis therapy