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

Primary Purpose

Neutropenia, Fungal Disease

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
micafungin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neutropenia

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micafungin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival rate
IFD-related mortality
Safety assessed by lab-test and adverse events
Safety profiles

Full Information

First Posted
August 9, 2011
Last Updated
July 11, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01417169
Brief Title
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Fungal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micafungin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
micafungin
Other Intervention Name(s)
Micafungin sodium, Mycamine
Intervention Description
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
Primary Outcome Measure Information:
Title
Absence rate of IFDs assessed by physical examination and serum galactomannan test
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Survival rate
Description
IFD-related mortality
Time Frame
100 days
Title
Safety assessed by lab-test and adverse events
Description
Safety profiles
Time Frame
4 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation Under 21 years old, pediatric, adolescent patients. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoung Jin Kang, M.D, Ph.D
Phone
82 2 2072 3304
Email
kanghj@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyery Kim, M.D.
Phone
82 2 2072 0177
Email
taban@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, M.D, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Chongno-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, M.D, Ph.D
Phone
82 2 2072 3304
Email
kanghj@snu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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