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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Transpl

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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival rate [ Time Frame: 100 days ]
    IFD-related mortality
  • Safety assessed by lab-test and adverse events [ Time Frame: 4 weeks ]
    Safety profiles


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: August 9, 2011
Date Started: August 2011
Date Completion: December 2014
Last Updated: July 11, 2014
Last Verified: July 2014