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Establishment of Prevention and Control System of Central Nervous System Infection

Establishment of Prevention and Control System of Central Nervous System Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04722328
Enrollment
715
Registered
2021-01-25
Start date
2021-03-01
Completion date
2025-12-31
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System (CNS) Infection, Encephalitis, Meningitis

Keywords

Central nervous system (CNS) infection, diagnosis, pathogen, Metagenomic next generation sequencing

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.

Interventions

DIAGNOSTIC_TESTCSF metagenomic next generation sequencing (mNGS)

TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* Non.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of pathogen detection1 month

Secondary

MeasureTime frame
I Identify the common pathogens of CNS infection3 year

Countries

China

Contacts

Primary ContactYan Zhang, Phd
zhangylq@sina.com0086-13671376710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026