CTRI/2016/02/006618尚未招募未知
A prospective randomized study comparing the safety and cost-effectiveness of antibiotic discontinuation without neutrophil recovery (ECIL approach) versus with neutrophil recovery (IDSA strategy) in young febrile-neutropenic patients with cancer - HRFN study
Dr Brijesh Arora0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
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
- •(1)Subjects with ages 2 to 24 years
- •(2)Receiving chemotherapy for a) newly diagnosed, relapsed or secondary AML; b) newly diagnosed ALL in induction or delayed intensification c) relapsed ALL in induction, consolidation, or intensification; d) advanced stage Burkitt lymphoma in induction or consolidation of LMB protocol.
- •(3)Febrile neutropenia defined as fever (temperature ï?³ 38ï?°C on two occasions within a 12 hour period or ï?³ 38.3ï?°C once) during neutropenia (absolute neutrophil count < 500 x 109 cells/L or absolute neutrophil count <1000 x 109 cells/L and falling) at least once during the 7 days prior to enrollment.
- •(4)At days 3-5, (A) meet criteria for antibiotic cessation consisting of: a) absence of fever (38.0° C) for at least 24 hours; (b) absence of a clinically or microbiologically documented infection for which antibiotic treatment after day 5 of febrile neutropenia would be required; and (c) absence of major co-morbidity such as severe grade 3 or greater (via CTCAE version 4.0) severe mucositis or abdominal pain, vomiting, hypotension, respiratory distress, or neurological signs or symptoms and (B) remain neutropenic with an absolute neutrophil count < 100 x 109 cells/L.
排除标准
- •(1)Previous enrollment on the trial
- •(2)Renal insufficiency on day 1 of febrile neutropenia defined via a calculated creatinine clearance < 70mL/min/1.73m2 or a higher than normal serum creatinine based on age/gender.
研究者
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