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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417169
First Posted: August 16, 2011
Last Update Posted: July 14, 2014
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.
Information provided by:
Seoul National University Hospital
  Purpose
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 Intervention Phase
Neutropenia Fungal Disease Drug: micafungin Phase 2

Study Type: Interventional
Study Design: 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 Autologous Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Absence rate of IFDs assessed by physical examination and serum galactomannan test [ Time Frame: 4 weeks ]
    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 [ Time Frame: 100 days ]
    IFD-related mortality

  • Safety assessed by lab-test and adverse events [ Time Frame: 4 weeks ]
    Safety profiles


Estimated Enrollment: 112
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micafungin 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
Other Names:
  • Micafungin sodium
  • Mycamine

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01417169


Contacts
Contact: Hyoung Jin Kang, M.D, Ph.D 82 2 2072 3304 kanghj@snu.ac.kr
Contact: Hyery Kim, M.D. 82 2 2072 0177 taban@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Chongno-gu, Korea, Republic of
Contact: Hyoung Jin Kang, M.D, Ph.D    82 2 2072 3304    kanghj@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyoung Jin Kang, M.D, Ph.D Seoul National University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01417169     History of Changes
Other Study ID Numbers: SNUCH-1102
First Submitted: August 9, 2011
First Posted: August 16, 2011
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Neutropenia
Mycoses
Invasive Fungal Infections
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents