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Establishment of Prevention and Control System of Central Nervous System Infection

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Capital Medical University

Status

Not yet enrolling

Conditions

Meningitis
Encephalitis
Central Nervous System (CNS) Infection

Treatments

Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)

Study type

Observational

Funder types

Other

Identifiers

NCT04722328
04 CNS infection

Details and patient eligibility

About

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.

Enrollment

715 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

715 participants in 2 patient groups

CNS infection
Treatment:
Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)
Non-CNS infection
Treatment:
Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)

Trial contacts and locations

1

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Central trial contact

Yan Zhang, Phd

Data sourced from clinicaltrials.gov

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