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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00003739
Registration number
NCT00003739
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
14/02/2014
Titles & IDs
Public title
Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
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Scientific title
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
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Secondary ID [1]
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COG-AS973
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Secondary ID [2]
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AS973
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fever, Sweats, and Hot Flashes
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Neutropenia
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Unspecified Childhood Solid Tumor, Protocol Specific
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Condition category
Condition code
Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Resolution of Febrile Neutropenia
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Assessment method [1]
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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.
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Timepoint [1]
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Secondary outcome [1]
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Incidence of Change of the Initial Empiric Antibiotic Treatment
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Assessment method [1]
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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.
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Timepoint [1]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Creatinine less than 1.5 times upper limit of normal
Renal:
* Not specified
Other:
* No patients in septic shock
* No prolonged fever of unknown origin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* See Chemotherapy
Chemotherapy:
* No prior or concurrent myeloablative chemoradiotherapy with bone marrow or peripheral stem cell rescue
Endocrine therapy:
* Not specified
Radiotherapy:
* See Chemotherapy
* No prior radiotherapy to marrow reserves (i.e., craniospinal and/or pelvic irradiation)
Surgery:
* Not specified
Other:
* At least 7 days since prior IV antibiotics
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Minimum age
No limit
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Maximum age
21
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
67
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2031 - Randwick
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
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Recruitment postcode(s) [6]
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00003739
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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M. F. Ozkaynak, MD
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Address
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New York Medical College
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Ozkaynak MF, Krailo M, Chen Z, Feusner J. Randomiz...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00003739
Download to PDF