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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Neutropenia; Fungal Disease

Treatments: Drug: micafungin

Study type: Interventional

Funder types: Other

Identifiers

NCT01417169

SNUCH-1102

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 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.

Enrollment: 112 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Micafungin

Experimental group

Treatment:

Drug: micafungin