Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- difference of positive rate between mNGS and Culture
研究概览
简要总结
mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. The purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. Anti-infective regimens can help.
详细描述
Sepsis patients in ICU were took blood culture sample and blood sample for mNGS test (IDSeqTM Ultra, Combing with Metagenomics and Pathogen/AMR/VF Probe Enrichment). Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. Validation with digital droplet PCR assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures The difference between the positive rate of mNGS and the positive rate of blood culture were recorded. Patient were followed at least 28 days after enrollment or an outcome indicator. Possible scenarios for detecting clinical impact were detected. Etiology, biochemical indicators, immune function, infection indicator, secondary infection, SOFA score and length of stay，outcome were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18years admit to ICU Meet the Sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of Sepsis ≤ 24 hours; Estimated ICU stay ≥ 24 hours; Informed consent;
排除标准
- •Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;
结局指标
主要结局
difference of positive rate between mNGS and Culture
时间窗: 28 day
The difference between the positive rate of mNGS and the positive rate of blood culture.
次要结局
- The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact(28 day)
- Length of stay(During hospitalization)
- Mortality(During hospitalization)
- Anti-infective treatment adjustment(28 day)
- Change of SOFA(7 day)
研究者
Ling Liu
Director
Southeast University, China