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

Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417169
• Other study ID #: SNUCH-1102
• Status: Recruiting
• Phase: Phase 2
• First received: August 9, 2011
• Last updated: July 11, 2014
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Seoul National University Hospital
• Contact: Hyoung Jin Kang, M.D, Ph.D
• Phone: 82 2 2072 3304
• Email: kanghj[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fungal Disease
• Mycoses
• Neutropenia

Intervention

Drug:
• micafungin
Eligible patients who provided informed consent form will be administered micafungin at 50 mg/day (1mg/kg/day for patients weighting <50kg) as 1-h infusion. Infusion of Micafungin will be started on the day -2 of the conditioning course of autologous stem cell transplantation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence rate of IFDs assessed by physical examination and serum galactomannan test	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	4 weeks	No
Secondary	Survival rate	IFD-related mortality	100 days	Yes
Secondary	Safety assessed by lab-test and adverse events	Safety profiles	4 weeks	No