Establishment of Prevention and Control System of Central Nervous System Infection

Not yet recruiting

• Conditions: Central Nervous System (CNS) Infection; Meningitis; Encephalitis
• Interventions: Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)

• Registration Number: NCT04722328
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-25
• Last Update Posted: 2021-01-25
• Study Start: 2021-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 715

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

• Non.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CNS infection	CSF metagenomic next generation sequencing (mNGS)	-
Non-CNS infection	CSF metagenomic next generation sequencing (mNGS)	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of pathogen detection	1 month

Secondary Outcome Measures

Name	Time	Method
I Identify the common pathogens of CNS infection	3 year

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, China