Clinical Application of Metagenomic Next-Generation Sequencing-Guided Anti-Infection Strategies in AIDS Patients With Severe Pneumonia and/or Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Pathogen detection rate and clinical diagnosis concordance rate
研究概览
简要总结
This study aims to observe the effectiveness of clinical application in guiding anti-infection treatments in AIDS patients with severe pneumonia and/or sepsis using Metagenomic Next-Generation Sequencing-based technology in the real world
详细描述
The study focuses on AIDS patients with severe pneumonia and/or sepsis, divided into groups based on whether metagenomic next-generation sequencing technology is used in the real world or not. The groups are the metagenomic next-generation sequencing group and the conventional pathogen detection group, with metagenomic sequencing samples derived from blood specimens. The study compares the pathogen detection rates and clinical diagnosis conformity rates of the aforementioned groups, as well as the efficiency of diagnosis in guiding clinical treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV infection;
- •Progression to AIDS stage: CD4+ count <200 cells/ul and/or occurrence of AIDS opportunistic infections;
- •Age between 18 and 65 years;
- •Meeting the diagnosis of severe pneumonia or septic shock:
- •The criteria for severe pneumonia diagnosis refer to the 2021 ATS (American Thoracic Society) and IDSA (Infectious Diseases Society of America) guidelines for the treatment of community-acquired pneumonia;
- •The criteria for septic shock refer to the Chinese Society of Critical Care Medicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018).
排除标准
- •Coexisting central nervous system lesions, severe liver disease, or cirrhosis;
- •Concurrent AIDS-related or unrelated tumors;
- •Women who are pregnant or breastfeeding;
- •Severe underlying diseases of the heart, lungs, liver, kidneys, etc.;
- •Alcohol abuse or drug use;
- •The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.
结局指标
主要结局
Pathogen detection rate and clinical diagnosis concordance rate
时间窗: 4 weeks
Analyze the concordance rate between the pathogen spectrum detected using pathogen metagenomics technology and the final clinical disease diagnosis.
次要结局
- Clinical treatment efficacy rate(4 weeks)
研究者
Linghua LI
Chief physician
Guangzhou 8th People's Hospital