Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research (MEMBER Research)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To elucidate the etiology and epidemiology of CNS infection all around China
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Mental disorders,
- •Abnormal behavior,
- •Unconsciousness or coma,
- •Dyskinesia or involuntary movement,
- •lalopathy or be reticent,
- •Dysphagia, sleep disorders, or autonomic nervous dysfunction,
- •Patients with meningeal irritation sign, intracranial hypertension and other manifestations, satisfy at least 3 of the following symptoms:
- •Stiff neck,
- •Disturbance of consciousness,
- •Kernig sign or brudzinski sign was positive.
排除标准
- •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.
结局指标
主要结局
To elucidate the etiology and epidemiology of CNS infection all around China
时间窗: within 2 weeks
The Investigators use mNGS method to describe central nervous system infection spectrum.
次要结局
未报告次要终点
研究者
Jia Wei Wang,MD,PhD
MD, PhD, Professor
Beijing Tongren Hospital