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临床试验/NCT02868593
NCT02868593Unknown不适用

Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,800
试验地点
1
主要终点
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis

研究概览

简要总结

The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.

详细描述

Community-based meningitis and meningo-encephalitis are defined by the presence of more than 10 leukocytes per mL of cerebrospinal fluid (CSF), eventually reported to the number of red blood cells. They can be associated with encephalitis, defined by cerebral or cerebellar dysfunction in the case of the transmission. The evolution includes death, what makes the seriousness of this clinical situation. However the diagnostic performance of meningitis and meningo-encephalitis in a patient without contact with a care structure is less than 25% resulting in empirical support in half of the patients. Indeed, the microbiological diagnosis of meningitis and transmission target currently only five pathogens including HIV positive resulted in a significant change to support the patient in three areas, decision of hospitalization, decision of isolation and antibiotic or antiviral treatment decision. A weekly epidemiological monitoring of the microbiological diagnosis of meningitis and meningo-encephalitis has enabled us to see a mismatch between a curve of requests for analyses and a flat curve of produced diagnoses. This discrepancy is interpreted as indicating a community outbreak of meningitis or meningo-encephalitis non-diagnosed by routine methods, called orphan meningitis or orphan meningo-encephalitis. On this observation, our research project is to improve the performance of the etiological diagnosis of community-based meningitis or meningo-encephalitis. To do this, we will evaluate the diagnostic performance of an advanced technique, using a non-invasive sample, the pharyngeal swab from the patient, to find micro-organisms that are not part of the commensal flora of the pharynx and who are responsible for undetected in routine meningitis. Indeed the main pathogens and meningitis (enterovirus, pneumococcus, meningococcus) transmission give a pharyngeal carriage before being responsible for meningitis or meningo-encephalitis. These bacteria are Coxiella burnetii, Bartonella spp., Tropheryma whipplei, Leptospira spp. and Borrelia spp.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patient is aged more than 18 years old.
  • Patient with clinical meningitis or meningo-encephalitis with community transmission.
  • Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
  • Patient who do not declined to have his medical records reviewed for research
  • Patient with health insurance

排除标准

  • Minor Patient (age <18 years)
  • Pregnant woman, parturient or breastfeeding
  • Adult Patient under guardianship
  • Patient deprived of liberty under court order
  • Patient vital in emergency.

结局指标

主要结局

Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis

时间窗: 1 day

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 (1)

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