Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00003739|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 14, 2014
RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Fever, Sweats, and Hot Flashes Neutropenia Unspecified Childhood Solid Tumor, Protocol Specific||Biological: filgrastim||Phase 3|
- Determine whether filgrastim (G-CSF) used in addition to standard antibiotic therapy accelerates time to resolution of febrile neutropenia in children receiving chemotherapy.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive standard antibiotic therapy.
- Arm II: Patients receive treatment as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously or IV once a day until at least 2 consecutive afebrile days have passed and absolute neutrophil count is at least 500/mm3.
Patients are followed for 3 days.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||September 2006|
U.S. FDA Resources
- Time to Resolution of Febrile NeutropeniaTime to Resolution of Febrile Neutropenia (Days of antibiotic treatment until the resolution of febrile neutropenia): The time to resolution of febrile neutropenia is defined as the number of days elapsed before the first day with both a temperature of less than 38.0oC and an ANC of equal to or greater than 500/μL.
- Incidence of Change of the Initial Empiric Antibiotic TreatmentThe Incidence of Change of the Initial Empiric Antibiotic Treatment: Any change in the initial empiric broad spectrum antibiotic treatment made during the febrile neutropenia period. There may be changes made in the antibiotic(s) after the resolution of febrile neutropenia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003739
Show 235 Study Locations
|Study Chair:||M. F. Ozkaynak, MD||New York Medical College|