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Status unknownNCT04724876MEMBERUpdated Jan 26, 2021

Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research

An observational study in Central Nervous System Infections and Inflammations, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.

Sponsored by Beijing Tongren Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
14 Years and older
Sex
All
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Study summary

Autoimmune encephalitis (AE) is caused by abnormal immune response mediated by autoimmune antibodies of patients, which can be detected by a serial of autoimmune antibodies[4,5,6,7]. At present, the traditional infection diagnosis mainly relies on microbial culture method, which has the characteristics of long cycle, high cost, low detection rate and complex detection process. About 30-60% of encephalitis have unknown etiology[2,3]. On the other hand, the diagnosis and classification of noninfectious encephalitis mainly depend on the detection of autoimmune antibodies, the scope of diagnosis and differential diagnosis is limited, and the relationship between autoimmune encephalitis and infection factors is still unclear. Metagenomics sequencing (mNGS) is a new method that does not rely on microbial culture and can directly detect pathogenic nucleic acids. It has the characteristics of fast, accurate, high throughput, no preference for different pathogen detection, and can detect known and unknown pathogens at the same time. Nowadays, mNGS is widely used in the field of pathogen detection.

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Conditions studied

  • Central Nervous System Infections and Inflammations
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In context

Central Nervous System Infections

36 studies on the registry are indexed under Central Nervous System Infections; 10 are open to participants now.

This study's planned enrollment of 300 is below the median of 537 across 24 observational studies indexed under Central Nervous System Infections.

Browse Central Nervous System Infections studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with suspected central nervous system infection.

Inclusion criteria

  • Either meet the items of 1, 2 or 1, 3

    1. The patient's age >14 years old, acute or subacute onset (less than 3 months), (first onset, treatment with anti-infection drugs and/or immunotherapy ≤5 days);
    2. The patient has the following symptoms:

      1. Dysmnesia,
      2. Seizures,
      3. Mental disorders,
      4. Abnormal behavior,
      5. Unconsciousness or coma,
      6. Dyskinesia or involuntary movement,
      7. lalopathy or be reticent,
      8. Dysphagia, sleep disorders, or autonomic nervous dysfunction,
      9. Ataxia.
    3. Patients with meningeal irritation sign, intracranial hypertension and other manifestations, satisfy at least 3 of the following symptoms:

      1. Headache,
      2. Fever,
      3. Stiff neck,
      4. Disturbance of consciousness,
      5. Kernig sign or brudzinski sign was positive.

Exclusion criteria

Exclusion Criteria:

    1. Patients with suspected metabolic encephalopathy and toxic encephalopathy have the above manifestations,
    1. Patients with central nervous system tumor (primary or metastatic) have the above manifestations,
    1. The patient with non-organic mental illness,
    1. Patients who had undergone brain surgery within 6 months have the above symptoms after operation,
    1. Patients with traumatic brain injury have the above manifestations,
    1. Febrile convulsions caused by non-cerebral causes,
    1. Patients with above manifestations due to other reasons such as cerebrovascular disease, genetic disease, etc;
    1. Patients who refuse lumbar puncture or have contraindications to lumbar puncture;
    1. Patients who withdraw informed consent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. To elucidate the etiology and epidemiology of CNS infection all around China

    The Investigators use mNGS method to describe central nervous system infection spectrum.

    Time frame: within 2 weeks

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Study locations

1 of 1 sites recruiting
  • Beijing Tongren Hospital,Capital Medical University
    Beijing, Beijing 100730, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04724876
Lead sponsor
Beijing Tongren Hospital
Collaborators
Beijing Tiantan Hospital, Air Force Military Medical University, China, Peking Union Medical College Hospital, The Second Hospital of Hebei Medical University, First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Xuanwu Hospital, Beijing, Third Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital, Fudan University, West China Hospital, Henan Provincial People's Hospital, Central South University, The First Affiliated Hospital of Shanxi Medical University
Responsible party
Jia Wei Wang,MD,PhD (MD, PhD, Professor, Beijing Tongren Hospital) — Principal investigator
First posted
Jan 26, 2021
Start date
Dec 31, 2020
Primary completion
Jun 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Jan 26, 2021

Study contacts

Jiawei Wang, Doctor
Contact
pengyujing1206@163.com
18811612263
Jiawei Wang, Doctor
principal investigator · Beijing Tong Ren Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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