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

Asan Medical Center

Status and phase

Unknown

Phase 4

Conditions

Neutropenia

Invasive Fungal Disease

Hematopoietic Stem Cell Transplantation

Treatments

Drug: Micafungin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01135589

KSPHO 2010-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 estimated patients

Sex

All

Ages

Under 19 years old

Volunteers

No 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