Establishment of Prevention and Control System of Central Nervous System Infection

Meningitis Clinical Trial

Official title:

Establishment of Prevention and Control System of Central Nervous System Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04722328
• Other study ID #: 04 CNS infection
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Yan Zhang, Phd
• Phone: 0086-13671376710
• Email: zhangylq[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 715
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System (CNS) Infection
• Central Nervous System Infections
• Communicable Diseases
• Encephalitis
• Infection
• Meningitis

Intervention

Diagnostic Test:
• CSF metagenomic next generation sequencing (mNGS)
TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS?

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of pathogen detection		1 month
Secondary	I Identify the common pathogens of CNS infection		3 year