跳至主要内容
临床试验/NCT07035535
NCT07035535Enrolling By Invitation不适用

The Predictive Value of Targeted Next-generation Sequencing(tNGS) in the Antimicrobial- Resistance Phenotypes of Pathogens

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
The outcome of the antimicrobial-resistance genes by tNGS

研究概览

简要总结

This observational study is to learn about the predictive value of targeted next-generation sequencing(tNGS) in pathogen resistance phenotype of patients with lower respiratory tract infection ,by detecting antimicrobial-resistant genes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years and above
  • Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 10*10^9/L or less than 4*10^9/L), and the presence of purulent tracheal secretions.
  • Patients have been performed tNGS test in-hospital, with the criterion that the reads per kilobase per million mapped reads(RPKM) for staphylococcus aureus exceeds 200, acinetobacter baumannii exceeds 300, klebsiella pneumoniae exceeds 20, or pseudomonas aeruginosa exceeds 100.

排除标准

  • Klebsiella pneumoniae,acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus were not cultured in BALF.

结局指标

主要结局

The outcome of the antimicrobial-resistance genes by tNGS

时间窗: Up to 2 weeks after enrollment

The investigators use the targeted next-generation sequencing(tNGS) to detect the antimicrobial-resistance genes produced by klebsiella pneumoniae,acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus in patients with lower respiratory tract infections

The outcome of bacteria antimicrobial susceptibility test

时间窗: Up to 2 weeks after enrollment

The antimicrobial susceptibility test(AST) results of the klebsiella pneumoniae,acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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