Clinical Trial: Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
Study Status: Terminated
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 Allogeneic 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 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.
Sponsor: Asan Medical Center
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Survival rate [ Time Frame: at day 100 ]
- Safety assessed by lab-test and adverse events [ Time Frame: during micafungin prophylaxis therapy ]
Original Secondary Outcome: Same as current
Information By: Asan Medical Center
Dates:
Date Received: May 25, 2010
Date Started: April 2010
Date Completion: May 2012
Last Updated: September 27, 2010
Last Verified: June 2010
