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临床试验/NCT04722328
NCT04722328尚未招募不适用

Establishment of Prevention and Control System of Central Nervous System Infection

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 715 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
715
试验地点
1
主要终点
Sensitivity and specificity of pathogen detection

研究概览

简要总结

Central nervous system (CNS) infection is a common nervous system acute and severe disease, mainly manifested as encephalitis, meningitis and meningoencephalitis, but also manifested as brain abscess and brain granuloma et al. The basis for the diagnosis of CNS infection lies in the detection of pathogens from brain parenchyma or cerebellar spinal fluid (CSF). However, CSF is relatively difficult to obtain and the sample size is small, which limits the rapid and definite diagnosis of CNS infection pathogens. In addition, CNS infection usually has non-specific clinical manifestations, so it is difficult to identify the pathogen for about half of CNS infection. Metagenomic next generation sequencing (mNGS) and biochip technology provide new means to identify the pathogens of CNS infection. This study analyzes the incidence and epidemic characteristics of CNS infection in China, to standardize the CSF sample processing process, shorten the detection time, increase the sensitivity and specificity of pathogen detection, reduce the detection cost, identify the common pathogens of CNS infection, and establish a standardized rapid diagnosis system, effective prevention and control system.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical suspected encephalitis or meningitis; onset time within 1 month; modified Rankin Scale (MRS) < 2 points before onset; informed consent of patients; patients who can not express their personal wishes due to aphasia, disturbance of consciousness and other reasons need to obtain the informed consent of their authorized relatives.

排除标准

  • 未提供

结局指标

主要结局

Sensitivity and specificity of pathogen detection

时间窗: 1 month

次要结局

  • I Identify the common pathogens of CNS infection(3 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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