COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01135589
Recruitment Status : Unknown
Verified June 2010 by Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 3, 2010
Last Update Posted : September 28, 2010
Astellas Pharma Korea, Inc.
Information provided by:
Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Neutropenia Hematopoietic Stem Cell Transplantation Invasive Fungal Disease Drug: Micafungin Phase 4

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study Start Date : April 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HSCT Drug: Micafungin
Other Names:
  • FK463
  • Fungard

Primary Outcome Measures :
  1. Absence rate of IFDs assessed by physical examination and serum galactomannan test [ Time Frame: during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis ]

Secondary Outcome Measures :
  1. Survival rate [ Time Frame: at day 100 ]
  2. Safety assessed by lab-test and adverse events [ Time Frame: during micafungin prophylaxis therapy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01135589

Layout table for location contacts
Contact: Clinical Development Administration Dept.

Layout table for location information
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Goyang, Korea, Republic of
Hwasun, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Astellas Pharma Korea, Inc.
Layout table for investigator information
Study Chair: Use Central Contact Astellas Pharma Inc
Layout table for additonal information
Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT01135589    
Other Study ID Numbers: KSPHO 2010-02
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: June 2010
Keywords provided by Asan Medical Center:
Additional relevant MeSH terms:
Layout table for MeSH terms
Invasive Fungal Infections
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Anti-Infective Agents