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Clinical Trials/NCT04722328
NCT04722328Not yet recruitingNot Applicable

Establishment of Prevention and Control System of Central Nervous System Infection

Xuanwu Hospital, Beijing1 site in 1 country715 target enrollmentStarted: March 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
715
Locations
1
Primary Endpoint
Sensitivity and specificity of pathogen detection

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sensitivity and specificity of pathogen detection

Time Frame: 1 month

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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