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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01417169
First received: August 9, 2011
Last updated: July 11, 2014
Last verified: July 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    IFD-related mortality

  • Safety assessed by lab-test and adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01417169     History of Changes
Other Study ID Numbers: SNUCH-1102
Study First Received: August 9, 2011
Last Updated: July 11, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014