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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01135589

Enrollment

145

Registered

2010-06-03

Start date

2010-04-30

Completion date

2012-05-31

Last updated

2010-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease, Neutropenia

Keywords

pediatric, adolescent, micafungin

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.

Interventions

DRUGMicafungin

i.v.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 19 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

South Korea

Contacts

Primary ContactClinical Development Administration Dept.

clinicaltrials_info@jp.astellas.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026