Establishment of Prevention and Control System of Central Nervous System Infection

January 19, 2021 updated by: Xuanwu Hospital, Beijing
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

715

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Xuanwu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CNS infection
Diagnostic test: CSF metagenomic next generation sequencing (mNGS)
TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。
Other Names:
  • CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.
Non-CNS infection
Diagnostic test: CSF metagenomic next generation sequencing (mNGS)
TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。
Other Names:
  • CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of pathogen detection
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
I Identify the common pathogens of CNS infection
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Study Chair: Yingfeng Wu, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (ACTUAL)

January 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04 CNS infection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The number, age, gender, diagnosis and outcome of the cases.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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