Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research

Central Nervous System Infections and Inflammations Clinical Trial

— MEMBER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724876
• Other study ID #: TRECKY2020-141
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: June 2023

Study information

• Verified date: January 2021
• Source: Beijing Tongren Hospital
• Contact: Jiawei Wang, Doctor
• Phone: 18811612263
• Email: pengyujing1206[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Infections
• Central Nervous System Infections and Inflammations
• Encephalitis
• Inflammation
• Meningitis

Locations

Country	Name	City	State
China	Beijing Tongren Hospital,Capital Medical University	Beijing	Beijing

Sponsors (15)

Lead Sponsor

Collaborator

Beijing Tongren Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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