Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research

NCT ID: NCT04724876

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-31

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Central Nervous System Infections and Inflammations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jia Wei Wang,MD,PhD

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiawei Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Tong Ren Hospital

Locations

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Beijing Tongren Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiawei Wang, Doctor

Role: CONTACT

18811612263

Facility Contacts

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Jiawei Wang, doctor

Role: primary

18811612263

Other Identifiers

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TRECKY2020-141

Identifier Type: -

Identifier Source: org_study_id

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