NCT01417169

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

Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Neutropenia
• Fungal Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-08-16
• Last updated: 2014-07-14

Locations

1 site across 1 country: South Korea