Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003739
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 14, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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

Detailed Description:


  • 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
Allocation: Randomized
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
Primary Completion Date : December 2002
Study Completion Date : September 2006

Primary Outcome Measures :
  1. Time to Resolution of Febrile Neutropenia
    Time 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.

Secondary Outcome Measures :
  1. Incidence of Change of the Initial Empiric Antibiotic Treatment
    The 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically diagnosed cancer with fever and chemotherapy-induced neutropenia (absolute neutrophil count no greater than 500/mm3)

    • Acute onset of fever of at least 38.8 degrees Celsius that is not related to the administration of blood products or pyrogenic substances
  • No acute myelogenous leukemia
  • No myelodysplastic syndrome
  • No solid tumor with bone marrow involvement



  • 21 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Creatinine less than 1.5 times upper limit of normal


  • Not specified


  • No patients in septic shock
  • No prolonged fever of unknown origin


Biologic therapy:

  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • See Chemotherapy


  • No prior or concurrent myeloablative chemoradiotherapy with bone marrow or peripheral stem cell rescue

Endocrine therapy:

  • Not specified


  • See Chemotherapy
  • No prior radiotherapy to marrow reserves (i.e., craniospinal and/or pelvic irradiation)


  • Not specified


  • At least 7 days since prior IV antibiotics

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003739

  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: M. F. Ozkaynak, MD New York Medical College

Publications of Results:
Ozkaynak MF, Krailo M, Chen N, et al.: Randomized comparison of antibiotics alone and with granulocyte colony-stimulating factor (G-CSF) in children with chemotherapy-induced febrile neutropenia: a report from the Children's Oncology Group. [Abstract] 2004 Pediatric Academic Societies' Annual Meeting, May 1-4, San Francisco, California. A-1769, 2004. Available online Last accessed August 29, 2005.

Responsible Party: Children's Oncology Group Identifier: NCT00003739     History of Changes
Other Study ID Numbers: AS973
COG-AS973 ( Other Identifier: Children's Oncology Group )
COG-S9703 ( Other Identifier: Children's Oncology Group )
CCG-S9703 ( Other Identifier: Children's Cancer Group )
COG-973 ( Other Identifier: Children's Oncology Group )
CDR0000066854 ( Other Identifier: Clinical )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific
fever, sweats, and hot flashes

Additional relevant MeSH terms:
Hot Flashes
Chemotherapy-Induced Febrile Neutropenia
Body Temperature Changes
Signs and Symptoms
Leukocyte Disorders
Hematologic Diseases
Febrile Neutropenia
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs