Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- tNGS for pathogen detection rate and drug resistance rate in VAP
研究概览
简要总结
Main purpose: To evaluate the feasibility of tNGS for pathogen detection and drug resistance analysis in VAP patients.
Research site and research population:
This study is planned to be conducted in hospitals, targeting VAP patients. Perform clinical routine testing and tNGS testing on lower respiratory tract samples (BALF) from VAP patients, and collect patient clinical information. Clinical routine testing includes culture (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on positive culture samples as needed. Finally, compare the consistency of tNGS detection results with clinical culture, comprehensive diagnosis, and drug sensitivity results. Further validation was conducted on consistent negative or inconsistent samples through PCR and mNGS.
详细描述
The investigators plan to include 150 VAP patients in the ICU. Lower respiratory tract samples (BALF) from VAP patients were routinely tested and tNGS tested, and clinical information was collected. Routine clinical tests include culture (necessary), microscopic examination, serology, PCR, etc., and drug sensitivity tests are performed on positive culture samples as required. Finally, the consistency of tNGS test results with clinical culture, comprehensive diagnosis and drug sensitivity results was compared. The uniformly negative or inconsistent samples were further verified by PCR and mNGS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)VAP patients (2) Patients can collect the required test information
排除标准
- •(1) Clearly diagnosed as non-infectious patients
- •(2) Insufficient samples or patients unwilling to participate
- •(3) Life expectancy is less than 24 hours
- •(4) Patients' clinical information cannot be obtained
结局指标
主要结局
tNGS for pathogen detection rate and drug resistance rate in VAP
时间窗: 2years
Evaluating the feasibility of tNGS for pathogen detection rate and drug resistance rate in VAP patients
次要结局
- Consistency rate of pathogen detection of tNGS with clinical practice(2 years)