Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever, Sweats, and Hot Flashes | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to Resolution of Febrile Neutropenia
- description
- 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)
- measure
- Incidence of Change of the Initial Empiric Antibiotic Treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTOzkaynak 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 15806544