Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using Metagenomics Next Generation Sequencing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- The accuracy of mNGS diagnosis in identification of pathogens in children with VAP.
研究概览
简要总结
VAP（Ventilator-associated pneumonia）is the most common complication of mechanical ventilation in severely ill patients. VAP is defined as pneumonia occurring 48 hours after patients receive mechanical ventilation, including pneumonia occurring within 48 hours after extubation. It is one of the important causes of hospital-acquired infection, and the incidence of VAP in children on mechanical ventilation is about 10%, or 7/1000 days of mechanical ventilation, and the overall mortality is 10-24%.Research has so far explained the relationship between bacteria isolated from human biological samples and VAP pathogens. Most studies are limited to the level of bacterial species, and there are few reports on bacterial genotyping, and there is a lack of scientific basis for the pathogenesis of VAP caused by bacteria in ventilator pipeline. The aim of the study is to investigate pathogen of the sputum in deep respiratory tract of patients with mechanical ventilation in PICU by the means of second generation sequencing (NGS).
详细描述
Children receiving invasive mechanical ventilation in the intensive care unit (PICU) of the Pediatric Hospital of Fudan University will be included. Deep sputum samples were collected within 24 h and on day 5 of mechanical ventilation, respectively, and sent for NGS at the same time. Sputum etiology examination is performed with sputum culture blood free DNA test.
The basic clinical data of the children (age, sex, weight, PICU diagnosis and other basic information, as well as the time of start and end of invasive mechanical ventilation for basic diseases, Glasgow coma score (GCS score), 3rd generation pediatric mortality risk score III(Prism III score), CRP, PCT, white blood cell count and body temperature will be recorded。 Clinical data related to the use of glucocorticoids, antibiotics and other drugs as well as life support such as renal replacement therapy, extracorporeal membrane, lung oxygenation and other life support were collected. Time and method of diagnosis of VAP pathogens were collected.
By comparing sensitivity and specificity of NGS and conventional sputum specimens for detection of VAP, the clinical value of mNGS in VAP will be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 29 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The time of invasive mechanical ventilation was less than 24 h when admitted to PICU Total duration of invasive mechanical ventilation is over 5 days
排除标准
- •Participants in other clinical trials in the same period No Informed Consent signed
研究组 & 干预措施
VAP group
Children with respiratory tract infection by mechanical ventilation
干预措施: mNGS diagnose of VAP (Diagnostic Test)
结局指标
主要结局
The accuracy of mNGS diagnosis in identification of pathogens in children with VAP.
时间窗: within 28 days after being discharged from PICU
The accuracy of combined diagnosis includes sensitivity and specificity. The reference standard test ( bacterial culture or virus PCR detection) and mNGS diagnosis are conducted in the cohort of pediatric children diagnosed of VAP
次要结局
未报告次要终点