Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 235
- 主要终点
- Time to Resolution of Febrile Neutropenia
研究概览
简要总结
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.
详细描述
OBJECTIVES:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •21 and under
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •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
- •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)
- •Not specified
- •At least 7 days since prior IV antibiotics
排除标准
- 未提供
结局指标
主要结局
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.
次要结局
- Incidence of Change of the Initial Empiric Antibiotic Treatment