Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- febrile rate
研究概览
简要总结
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.
The current study will evaluate the three different regimen:
- No prophylaxic antibiotic
- Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
- Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
详细描述
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the neutropenia patients into 3 groups.
- Receive 3 regimen.
- Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
- For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-65 years
- •Received Autologous or Allogeneic hematopoietic stem cell transplantation.
- •ECOG score 0-
- •ICF is available.
排除标准
- •Allergic to any therapy drug.
- •Documented infection before neutropenia.
- •Renal dysfunction.
- •Suffering from central nervous system or mental disease.
研究组 & 干预措施
piperacillin
干预措施: Piperacillin (Drug)
piperacillin/tazobactam
干预措施: Piperacillin-tazobactam combination product (Drug)
结局指标
主要结局
febrile rate
时间窗: 3 weeks after beginning of prophylaxis
In both group, how many patients developed febrile.
次要结局
- Microbiologic efficacy in febrile patients(3 weeks after beginning of prophylaxis)
- Recovery rate from neutropenia(3 weeks after beginning of prophylaxis)
- AE(3 weeks after beginning of prophylaxis)
- Cost of drug and hospital-stay(3 weeks after beginning of prophylaxis)
研究者
Wenrong Huang
Associate director, Hematology, Chinese PLA General hospital
Chinese PLA General Hospital