CTRI/2010/091/000177已完成3 期
A randomized open labeled parallel group phase III study of antibiotics alone versus antibiotics plus granulocyte-colony-stimulating factor in pediatric patients with chemotherapy induced febrile neutropenia in a developing country.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects admitted for fever and chemotherapy -induced neutropenia who have been on protocols that do not utilize prophylactic G-CSF will be eligible.Patients must present with an acute onset of fever of equal to or greater than 38.3 degrees celcius and absolute neutrophil count <500 /meu l
排除标准
- •1.patients with acute myelogenous leukemia and myelodysplastic syndrome.
- •2.Patients with septic shock.
- •3.Patients treated with IV anitbiotics within 7 days
- •4.Prolonged fever of unknown origin in patients who have undergone standard fever evaluation.
- •5.Patients could have been treated with growth factors in the past, but all patients who are being treated with any haemopoetic growth factors.eg G-CSF, GM -CSF at the time of study entrygrowth factors
- •6.ALL patients on induction or not in remission after induction
- •7.Patients with renal impairment:serum creatinine equal to or higher than 1.5 x normal.
- •8.Patients who have had radiotherapy to marrow reserves.i.e craniospinal and and /or pelvic irradiation
- •9.Solid tumor patients with bone marrow involvement
研究者
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