Overview

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

Status:
Unknown status

Trial end date:
2014-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Seoul National University Hospital

Treatments:

Echinocandins
Micafungin

Criteria

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