Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research

NCT04724876 | Unknown DMC

• 1 other identifier: TRECKY2020-141
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Nervous System Infections and Inflammations

Outcome Measures

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.

  within 2 weeks

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected central nervous system infection.

You may qualify if:

• Either meet the items of 1, 2 or 1, 3
• 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);
• The patient has the following symptoms:
• Dysmnesia,
• Seizures,
• Mental disorders,
• Abnormal behavior,
• Unconsciousness or coma,
• Dyskinesia or involuntary movement,
• lalopathy or be reticent,
• Dysphagia, sleep disorders, or autonomic nervous dysfunction,
• Ataxia.
• Patients with meningeal irritation sign, intracranial hypertension and other manifestations, satisfy at least 3 of the following symptoms:
• Headache,
• Fever,

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Air Force Military Medical University, China: collaborator
• Peking Union Medical College Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Chinese PLA General Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shandong Provincial Hospital: collaborator
• Fudan University: collaborator
• West China Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Central South University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator

Study Sites (1)

Beijing Tongren Hospital,Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood; serum; cerebrospinal fluid

MeSH Terms

Conditions

Central Nervous System Infections; Inflammation

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiawei Wang, Doctor

  Beijing Tong Ren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiawei Wang, Doctor

CONTACT

18811612263; pengyujing1206@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: January 26, 2021
• Study Start: December 31, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

CN (1)