How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the fractional inhibitory concentration index (FICI)
研究概览
简要总结
The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.
详细描述
- Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital.
- Separate and purify the BALF. Divide each CRKP into four treatment groups based on meropenem.
3.1 By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results.
3.2 Observe the effect of two antibiotics on the growth of CRKP by TKA.
4.By the above two invitro experiments, analyze the data of the experimental results and get the best combination therapy based on carbapenems.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 to
- •infected with CRKP firstly .
排除标准
- •APACHE II score > 35
- •Vital signs are unstable
- •Unable to tolerate fiberoptic bronchoscopy
研究组 & 干预措施
only meropenem therapy,
this group is only meropenem therapy as a single antibiotic treatment
干预措施: Fosfomycin (Drug)
only meropenem therapy,
this group is only meropenem therapy as a single antibiotic treatment
干预措施: Tigecycline (Drug)
only meropenem therapy,
this group is only meropenem therapy as a single antibiotic treatment
干预措施: Polymyxin B (Drug)
结局指标
主要结局
the fractional inhibitory concentration index (FICI)
时间窗: 24hours-36hours
By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results. Evaluation index: FIC=0.5 , coordinating effect. 0.5 \< FIC \<1, adding effect; 1 \< FIC \<2, irrelevant.
次要结局
- the time-kill assay (TKA)(36hours-48hours)
研究者
Sheng Wang MD PhD
Director
Shanghai 10th People's Hospital