Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 6
- 主要终点
- Number of days on which patient is free of antimicrobial treatment
研究概览
简要总结
Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).
详细描述
The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation.
- •Informed consent signed.
排除标准
- •Fever with etiologic diagnosis.
- •Patients with epilepsy.
- •Pregnant or lactating women.
- •Patients with HIV infection.
- •Patients with severe renal failure.
研究组 & 干预措施
Experimental Arm
Empirical antimicrobial treatment discontinuation
干预措施: Empirical antimicrobial treatment discontinuation (Drug)
Control Arm
Standard empirical antimicrobial treatment discontinuation
干预措施: Standard empirical antimicrobial treatment discontinuation (Drug)
结局指标
主要结局
Number of days on which patient is free of antimicrobial treatment
时间窗: 28 days following the initiation of empiric antibiotic treatment.
Protocol visits: Screening visit, Randomization visit, at 72h. of apyrexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit).
次要结局
- Crude mortality(28 days following the initiation of empiric antibiotic treatment.)
- Number of days of fever(28 days following the initiation of empiric antibiotic treatment)