Clinical Trials Logo
  1. Home
  2. Neutropenia
  3. NCT01135589

Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Neutropenia Clinical Trial

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 Transplantation

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01135589
Study type Interventional
Source Asan Medical Center
Contact Clinical Development Administration Dept.
Email clinicaltrials_info@jp.astellas.com
Status Recruiting
Phase Phase 4
Start date April 2010
Completion date May 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT02452034 - Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097) Phase 1
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A
Not yet recruiting NCT01714557 - Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Active, not recruiting NCT00020865 - Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia Phase 3
Completed NCT00257790 - The Tobramycin Study Phase 4
Completed NCT00020371 - BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy Phase 1
Terminated NCT00005787 - Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma Phase 1
Completed NCT00001533 - Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine Phase 1
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Not yet recruiting NCT02238873 - Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma Phase 3
Completed NCT01058993 - AMD 3100 for Treatment of Myelokathexis Phase 1
Completed NCT00771810 - Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer Phase 2
Completed NCT00770172 - G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy Phase 3
Completed NCT00771433 - G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer Phase 2
Terminated NCT00529282 - A Study of Ceftobiprole in Patients With Fever and Neutropenia. Phase 3
Active, not recruiting NCT00030758 - Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer Phase 4
Completed NCT00001790 - Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia Phase 1
Completed NCT00002693 - Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia Phase 1
Active, not recruiting NCT04154488 - A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders Phase 1/Phase 2