Establishment of Prevention and Control System of Central Nervous System Infection

NCT04722328 | Unknown

• 1 other identifier: 04 CNS infection
• Study Type: observational
• Target: 715
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System (CNS) Infection; Encephalitis; Meningitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of pathogen detection

  1 month

Secondary Outcomes (1)

• I Identify the common pathogens of CNS infection

  3 year

Study Arms (2)

CNS infection

Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)

Non-CNS infection

Diagnostic Test: CSF metagenomic next generation sequencing (mNGS)

Interventions

CSF metagenomic next generation sequencing (mNGS) DIAGNOSTIC_TEST

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

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

CNS infection; Non-CNS infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Criteria for clinical suspected encephalitis: acute or subacute onset, fever before and after the onset, symptoms and signs of brain parenchyma damage, including generalized or focal epilepsy (not related to previous epilepsy), mental and behavioral abnormalities, newly emerging local neurological deficit, disturbance of consciousness, etc. Clinical suspected meningitis criteria: acute or subacute onset, with fever, headache, vomiting, disturbance of consciousness and meningeal irritation as the main clinical manifestations, accompanied by cranial nerve and brain parenchyma damage.

You may qualify if:

• 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.

You may not qualify if:

• Non.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

MeSH Terms

Conditions

Infections; Encephalitis; Meningitis; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yingfeng Wu

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Yan Zhang, Phd

CONTACT

0086-13671376710; zhangylq@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: January 25, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)