Establishment of Prevention and Control System of Central Nervous System Infection

Study Overview
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Brief Summary
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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.

Official Title
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Establishment of Prevention and Control System of Central Nervous System Infection

Conditions
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Central Nervous System (CNS) Infection, Encephalitis, Meningitis

Intervention / Treatment
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* Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CNS infection<br> | Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)<br>* TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。<br>* Other names: CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.;|
| Non-CNS infection<br> | Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)<br>* TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。<br>* Other names: CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of pathogen detection |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I Identify the common pathogens of CNS infection |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central nervous system (CNS) infection, diagnosis, pathogen, Metagenomic next generation sequencing