Establishment of Prevention and Control System of Central Nervous System Infection

NCT ID: NCT04722328

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

715 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Central Nervous System (CNS) Infection Encephalitis Meningitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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CNS infection

CSF metagenomic next generation sequencing (mNGS)

Intervention Type DIAGNOSTIC_TEST

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

Non-CNS infection

CSF metagenomic next generation sequencing (mNGS)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CSF metagenomic next generation sequencing (mNGS)

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingfeng Wu

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yan Zhang, Phd

Role: CONTACT

0086-13671376710

Other Identifiers

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04 CNS infection

Identifier Type: -

Identifier Source: org_study_id

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