Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Days of no empirical antibiotics treatment
研究概览
简要总结
This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). In case of afebrile for 72 hours with empirical antibiotics treatment, patients will be randomized into 2 groups. In the early de-escalation group, antibiotics treatment will be stopped and prophylaxis with levofloxacin will be resumed. In the control group, the empirical treatment will continue until recovery of neutropenia or at least for 7 days.
详细描述
This is a randomized study to evaluate the safety and feasibility of early de-escalation treatment of empyrical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). All patients undergoing HSCT will receive levofloxacin as regular prophylaxis. After patients develop neutropenia fever, the empirical antibiotics protocol will be impenem. In case of persistent for 48 hours, vancomycin will be added. If afebrile is achieved for 72 hours, all patients will randomized into early de-escalating group or control group. In de-escalating group, the empirical antibiotics treatment will be stopped and then levofloxacin prophylaxis will be resumed. In the control group, the empirical antibiotics treatment will be continue until recovery of neutropenia or at least 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18，patients undergo hematopoietic stem cells
- •Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC <0.5x109/L or predicted to be <0.5x109/L in 24 ~48 hours；
- •Patients achieved afebrile （T<37.5°C）for at least 72 hours；
- •Inform consent given
排除标准
- •Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.
- •Patients with septic shock
- •Levofloaxin allergy or contra-indication
研究组 & 干预措施
Early de-escalation
In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours.
干预措施: Early de-escalation (Procedure)
Standard
In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.
干预措施: Standard (Procedure)
结局指标
主要结局
Days of no empirical antibiotics treatment
时间窗: 28 days
days from start of empirical antibiotics to end of study minus days with empirical antibiotics
次要结局
未报告次要终点
研究者
Jiong HU
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine