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临床试验/NCT02841254
NCT02841254已完成不适用

Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study

Nantes University Hospital3 个研究点 分布在 1 个国家目标入组 579 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
579
试验地点
3
主要终点
meningitis (either viral or bacterial) or absence of meningitis

研究概览

简要总结

Meningitis are serious infections. Evidenced by high rates of mortality and sequelae. However, these diseases have a relatively small impact. Also physician services Home Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis. Indeed, it is only after this essential clinical milestone that will be carried out a lumbar puncture which will confirm the diagnosis and to quickly begin treatment.

Unfortunately, if recent studies can improve the therapeutic management of patients with meningitis, no study was interested in yet fundamental step of diagnosis.

It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a predictive clinical score of the presence or absence of meningitis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • May be included in the study two groups of patients:
  • *On the one hand, those in which will be carried out a lumbar puncture. Ideally, all patients in whom the examination is envisaged will be included. The logistics must allow inclusion rate as high as possible (see below).
  • So, are included in this group, patients for which the following criteria are met:
  • Over 15 years patient and 3 months,
  • Admission to the emergency for less than 6 hours
  • Realization of a proposed lumbar puncture,
  • Information sheet given. *On the other hand, those in whom it is not intended to be carried by lumbar puncture, but for which the clinical picture present on admission makes relevant for clinical signs of meningitis.
  • So, are included in this group, patients for which the following criteria are met:
  • Over 15 years patient and 3 months,
  • Admission to the emergency for less than 6 hours
  • At least one of the following 5 clinical signs motivating consultation and / or present on admission:
  • fever (measured temperature above 38 ° C)
  • headache,
  • vomiting,
  • stiff neck,
  • vigilance disorders,
  • Information sheet given.

排除标准

  • Patient who underwent neurosurgery recent (within the month before admission).

结局指标

主要结局

meningitis (either viral or bacterial) or absence of meningitis

时间窗: Until 2 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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