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

Phase 2

• Conditions: Neutropenia; Fungal Disease
• Interventions: Drug: micafungin

• Registration Number: NCT01417169
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micafungin	micafungin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Survival rate	100 days	IFD-related mortality
Safety assessed by lab-test and adverse events	4 weeks	Safety profiles

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of