Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
7 other identifiers
interventional
67
7 countries
235
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 1999
Longer than P75 for phase_3
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 14, 2014
February 1, 2014
3.8 years
November 1, 1999
February 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (1)
Incidence of Change of the Initial Empiric Antibiotic Treatment
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (235)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35233, United States
University of South Alabama Medical Center
Mobile, Alabama, 36604, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Southern California Permanente Medical Group
Downey, California, 90242, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Jonathan Jaques Children's Cancer Center
Long Beach, California, 90801-1428, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Children's Hospital Central California
Madera, California, 93638-8762, United States
Children's Hospital of Oakland
Oakland, California, 94609-1809, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120, United States
Children's Hospital San Diego
San Diego, California, 92123-4282, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, 94115, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386, United States
David Grant Medical Center
Travis Air Force Base, California, 94535, United States
Children's Hospital of Denver
Denver, Colorado, 80218-1088, United States
Childhood Hematology/Oncology Associates
Denver, Colorado, 80218, United States
Presbyterian-St Luke's Medical Center
Denver, Colorado, 80218, United States
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028, United States
Alfred I. Dupont Institute
Wilmington, Delaware, 19899, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277, United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, 33021, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
University of Miami-Jackson Memorial Hospital
Miami, Florida, 33136, United States
Miami Children's Hospital
Miami, Florida, 33155-4069, United States
Baptist Hospital of Miami
Miami, Florida, 33176-2197, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32803, United States
Nemours Children's Clinic-Orlando
Orlando, Florida, 32806, United States
Sacred Heart Children's Hospital
Pensacola, Florida, 32504, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Tampa Children's Hospital
Tampa, Florida, 33677-4227, United States
St. Mary's Hospital
West Palm Beach, Florida, 33407, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, 30912-4000, United States
Medical Center of Central Georgia
Macon, Georgia, 31201, United States
Memorial Health University Medical Center, Inc.
Savannah, Georgia, 31403-3089, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60601, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614, United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Lutheran General Hospital
Park Ridge, Illinois, 60068-1174, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9658, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Raymond Blank Memorial Hospital for Children
Des Moines, Iowa, 50308, United States
John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0284, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202-3830, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201-1595, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Floating Hospital for Children
Boston, Massachusetts, 02111, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Mott Children's Hospital
Ann Arbor, Michigan, 48109-0914, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769, United States
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, 55805-1983, United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, 55404, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital of Omaha
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2168, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109-2306, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112-2094, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503, United States
Atlantic Health System
Summit, New Jersey, 07901, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131, United States
Cancer Center of Albany Medical Center
Albany, New York, 12208, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, 11203, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Schneider Children's Hospital
New Hyde Park, New York, 11042, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021-4885, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia Presbyterian Hospital
New York, New York, 10032, United States
James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775, United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, 10461, United States
New York Medical College
Valhalla, New York, 10595, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1081, United States
Dakota Cancer Institute
Fargo, North Dakota, 58103-4940, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696, United States
Children's Medical Center - Dayton
Dayton, Ohio, 45404, United States
Toledo Children's Hospital
Toledo, Ohio, 43601, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, 44501, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136, United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-1320, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02818, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, 29203, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-1080, United States
Sioux Valley Hospital
Sioux Falls, South Dakota, 57117, United States
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, 37604, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, 37901, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106, United States
Children's Hospital of Austin
Austin, Texas, 78701, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207, United States
Methodist Health Care System
San Antonio, Texas, 78229-3902, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-5100, United States
Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Carilion Medical Center for Children
Roanoke, Virginia, 24013, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Group Health Cooperative
Seattle, Washington, 98112, United States
Deaconess Medical Center
Spokane, Washington, 99210-0248, United States
Mary Bridge Children's Health Center
Tacoma, Washington, 98415-0299, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000, United States
West Virginia University - Charleston
Charleston, West Virginia, 25302, United States
Cabell-Huntington Hospital, Inc
Huntington, West Virginia, 25701, United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-9070, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449-5772, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Royal Children's Hospital
Brisbane, Queensland, 4029, Australia
Women's and Children's Hospital
North Adelaide, South Australia, 5006, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6001, Australia
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
Children's Hospital
Hamilton, Ontario, L8N 3Z5, Canada
Children's Hospital of Western Ontario
London, Ontario, N6C 2V5, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3, Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5, Canada
Laval University Medical Center
Sainte-Foy, Quebec, G1V 4G2, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Academisch Ziekenhuis Groningen
Groningen, 9700 RB, Netherlands
Starship Children's Hospital
Auckland, New Zealand
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067, Puerto Rico
San Jorge Childrens Hospital
Santurce, 00912, Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern, CH 3010, Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, CH 1211, Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, CH 1011, Switzerland
Related Publications (1)
Ozkaynak MF, Krailo M, Chen Z, Feusner J. Randomized comparison of antibiotics with and without granulocyte colony-stimulating factor in children with chemotherapy-induced febrile neutropenia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2005 Sep;45(3):274-80. doi: 10.1002/pbc.20366.
PMID: 15806544RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M. F. Ozkaynak, MD
New York Medical College
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE CARE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
March 1, 1999
Primary Completion
December 1, 2002
Study Completion
September 1, 2006
Last Updated
February 14, 2014
Record last verified: 2014-02