Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
研究概览
简要总结
Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are highly suspected of sepsis；
- •Patients are highly suspected of respiratory infections；
- •Patients are highly suspected of central nervous system infection；
- •Patients are highly suspected of fever of unknown origin
排除标准
- •Congenital malformations；
- •Patients requiring surgical intervention;
- •Patients with skin barrier dysfunction
结局指标
主要结局
The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
时间窗: From the date of first samples enrolled until the last samples detected, up to 3 years
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The specificity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
时间窗: From the date of first samples enrolled until the last samples detected, up to 3 years
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The sensitivity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
次要结局
未报告次要终点