Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research (MEMBER)

Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research (MEMBER Research)

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.

Study Overview

• Status: Recruiting
• Conditions: Central Nervous System Infections and Inflammations

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jiawei Wang, doctor; Phone Number: 18811612263; Email: pengyujing1206@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Tongren Hospital,Capital Medical University
      • Contact: Jiawei Wang, doctor; Phone Number: 18811612263; Email: pengyujing1206@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with suspected central nervous system infection.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: Fudan University; Peking Union Medical College Hospital; Beijing Tiantan Hospital; Chinese PLA General Hospital; The Second Hospital of Hebei Medical University; First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; Xuanwu Hospital, Beijing; Shandong Provincial Hospital; Henan Provincial People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Air Force Military Medical University, China; Central South University; The First Affiliated Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Jiawei Wang, Doctor, Beijing Tong Ren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Encephalitis; Inflammation; Meningitis; Central Nervous System Infections
• Other Study ID Numbers: TRECKY2020-141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No