Evaluation of Ceftazidime-avibactam Plus Aztreonam in Patients Infected by MBL-producing Enterobacterales and CRISPR/Cas9-based Strategy for Curing Drug-resistant Genes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- length of stay after diagnosis
研究概览
简要总结
The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. The investigators then use CRISPR/Cas9 technology to remove Enterobacteriaceae bacteria resistance and virulence genes
详细描述
Clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; Bacterial species names will be identified and drugs sensitivity will be detected; For patients with bloodstream infection of MBL-producing Enterobacterales, ceftazidime-avibactam (CAZ-AVI) was administered at the dose of 2.5 g every 8 hours and aztreonam (ATM) at the dose of 2 g every 8 hours.
The primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (LOS) after bloodstream infection diagnosis. Cox regression analysis, including a propensity score (PS) for receiving CAZ-AVI plus ATM, was conducted to assess the primary and secondary outcomes. The CRISPR/Cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of Enterobacteriaceae in the mouse intestinal colonization model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects clinically suspected of infection caused by Enterobacterales
- •Subjects with bloodstream infection by MBL-producing Enterobacterales
排除标准
- •Infections caused by viruses, fungi, atypical pathogens, and other non-Enterobacteriaceae bacteria
- •subjects who are unwilling to enter the research group
研究组 & 干预措施
CAZ/AVI plus Aztreonam
CAZ-AVI was administered at the dose of 2.5 g every 8 hours and ATM at the dose of 2 g every 8 hours
干预措施: CAZ/AVI plus Aztreonam (Drug)
Conventional treatment
Other active antibiotics were administered, including colistin, tigecycline, fosfomycin, meropenem.
干预措施: Conventional treatment (Other)
结局指标
主要结局
length of stay after diagnosis
时间窗: two years
length of stay (LOS) after blood stream infection diagnosis
clinical failure at day 14
时间窗: two years
severe comorbidities, mechanical ventilation or septic shock at day 14
30-day all-cause mortality
时间窗: two years
The primary outcome measure was 30-day all-cause mortality
次要结局
- Positive rate of Metallo-β-lactamases (MBL) producing Enterobacterales(two years)
研究者
Mingju Hao
Clinical Professor
Qianfoshan Hospital