Central Nervous System (CNS) InfectionNCT04722328
Establishment of Prevention and Control System of Central Nervous System Infection
An observational study of Central Nervous System (CNS) Infection and Encephalitis, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System (CNS) Infection, Encephalitis, Meningitis
- What is being tested?
- CSF metagenomic next generation sequencing (mNGS)
- How many people
- 715 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Non.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- CSF metagenomic next generation sequencing (mNGS)
- Keywords
- Central nervous system (CNS) infection, diagnosis, pathogen, Metagenomic next generation sequencing
- Medical subject headings
- Infections, Encephalitis, Meningitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF metagenomic next generation sequencing (mNGS)Diagnostic test
Also called CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.
TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。
| Study group | Role | What they receive |
|---|---|---|
| CNS infection | Not described Receives: Diagnostic Test: CSF metagenomic next generation sequencing (mNGS) | |
| Non-CNS infection | Not described Receives: Diagnostic Test: CSF metagenomic next generation sequencing (mNGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of pathogen detection
Measured: 1 month
Secondary outcomes (1)
I Identify the common pathogens of CNS infection
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System (CNS) InfectionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 715 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingfeng Wu, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722328
- Sponsor's protocol ID
- 04 CNS infection
- Status last verified
- Nov 2020
- First submitted
- 19 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The number, age, gender, diagnosis and outcome of the cases.
Publications
Tian F, Liu Z, Chen W, Cui L, Shan D, Zhang H, Chai S, Liu G, Fan L, Li G, Yang L, Zhang J, Zhao J, Hou F, Du J, Huan X, Lv Y, Huang X, Zhang R, Wu L, Wu Y, Zhang Y. A prognostic model for early risk stratification in adult community-acquired suspected CNS infections: multicenter development and external validation. BMC Infect Dis. 2025 Nov 17;25(1):1601. doi: 10.1186/s12879-025-11776-8.
PubMed 41249949
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Prevention and Control System of Central Nervous System Infection
- ClinicalTrials.gov ID
- NCT04722328
- Acronym / sponsor ID
- 04 CNS infection
- Keywords
- Central nervous system (CNS) infection, diagnosis, pathogen, Metagenomic next generation sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 715 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNS infection | – | Diagnostic Test: CSF metagenomic next generation sequencing (mNGS) |
| Non-CNS infection | – | Diagnostic Test: CSF metagenomic next generation sequencing (mNGS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF metagenomic next generation sequencing (mNGS)Also: CSF detection: routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture.TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。 | Diagnostic test | CNS infection, Non-CNS infection |
Primary outcome
Sensitivity and specificity of pathogen detection
Time frame: 1 month
1 secondary outcome
I Identify the common pathogens of CNS infection
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 41249949Tian F, Liu Z, Chen W, Cui L, Shan D, Zhang H, Chai S, Liu G, Fan L, Li G, Yang L, Zhang J, Zhao J, Hou F, Du J, Huan X, Lv Y, Huang X, Zhang R, Wu L, Wu Y, Zhang Y. A prognostic model for early risk stratification in adult community-acquired suspected CNS infections: multicenter development and external validation. BMC Infect Dis. 2025 Nov 17;25(1):1601. doi: 10.1186/s12879-025-11776-8.
- Individual participant dataSharing planned: No. The number, age, gender, diagnosis and outcome of the cases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingfeng Wu study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System (CNS) Infection and Encephalitis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang, Phd (0086-13671376710, zhangylq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of pathogen detection (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.