Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 484
- 试验地点
- 7
- 主要终点
- The change Modified Rankin Scale (mRS) at 1 year
研究概览
简要总结
Encephalitis and meningitis are serious central nervous system diseases. There is currently a lack of comprehensive and accurate diagnosis and treatment pathways. Therefore, we conducted this multicenter, prospective, and randomized controlled study. It was designed to evaluate the diagnostic performance and its impact on the outcomes of the patients enrolled. As such, we came to the results of the optimal process of diagnosis and treatment strategy of encephalitis/meningeal syndromes with improved effective treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected meningitis : the patient has a new fever (>38.5℃), accompanied by ≥1 of the following manifestations：
- •Change in state of consciousness
- •Other signs of meningitis: such as meningeal irritation.
- •Patients with suspected encephalitis: Unexplained changes in the state of consciousness for more than 24 hours (including lethargy, agitation, personality changes, etc.) or accompanied by recent memory impairment, with the following ≥1 manifestations:
- •Fever during the course of the disease (≥ 38℃); (oral temperature)
- •Convulsions or focal neurological symptoms;
- •Increase in the number of cerebrospinal fluid cells (>4*10^6/L);
- •Abnormal EEG that meets the manifestations of encephalitis and cannot be attributed to other reasons
- •Imaging suggests encephalitis (CT or MRI)
- •Have not received effective anti-infective treatment yet
- •Have an identifiable address and live in the area during treatment.
- •Suspected encephalitis/meningitis patients who are willing to participate in trial treatment and follow-up and can give informed consent (if the subject is illiterate, sign or hearing consent is required).
- •Willing to comply with follow-up research procedures.
排除标准
- •Known breastfeeding or pregnancy
- •Failure to comply with treatment or follow-up time;
- •The researcher believes that there are any conditions (social or medical) that allow subjects to participate in unsafe;
- •Participating in other clinical studies
- •Insufficient cerebrospinal fluid or blood samples
- •Clinically diagnosed infections, tumors or other neurological diseases
结局指标
主要结局
The change Modified Rankin Scale (mRS) at 1 year
时间窗: mRS should be measured at 1 year
The Modified Rankin Scale at 1 year Grade Description 0 No symptoms 1. Minor symptoms not interfering with lifestyle 2. Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients' ability to look after themselves 3. Symptoms that restrict lifestyle and prevent totally independent living 4. Symptoms that clearly prevent independent living, although the patient does not need constant care and attention 5. Totally dependent, requiring constant help day and night
次要结局
- Mortality rate at 1 year(Mortality rate at 1 year)
研究者
Wen-hong Zhang
chairman of the infectious disease department
Huashan Hospital