跳至主要内容
临床试验/NCT03418441
NCT03418441招募中不适用

Danish Study Group of Infections of the Brain: A Nationwide Prospective Observational Cohort Study of All Central Nervous System Infections in Adults at Departments of Infectious Diseases in Denmark

Aalborg University Hospital8 个研究点 分布在 1 个国家目标入组 1,900 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,900
试验地点
8
主要终点
Incidence

研究概览

简要总结

The Danish Study Group of Infections of the Brain is a collaboration between all departments of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in central nervous system (CNS) infections by a prospective registration of clinical characteristics and outcome of all adult (>17 years of age) patients with community-acquired CNS infections diagnosed and/or treated at departments of infectious diseases in Denmark since 1st of January 2015.

详细描述

The investigators include data on diagnosis at admission, symptoms and signs on admission, character and timing of diagnostic work-up and treatment and outcome assessed by the Glasgow Outcome Score (GOS).

Diagnostic work-up and treatment is left at the discretion of the local physician and therefore not standardised

In general any symptoms/deficits should only be listed if they are 'new' to the patient, e.g. a known palsy of the facial nerve should not be listed as a new relevant finding at admission. On the other hand, worsening of a known neurological deficit should be listed under signs in the given instrument (bacterial meningitis, encephalitis, neuroborreliosis etc). Likewise, for outcome only changes in pre-morbid conditions should be listed including place of residence, functional status, neurological deficits etc.

Time of admission is obtained in prioritized order from the ambulance charts or notifications of arrival by secretaries or nurses in the emergency departments. Timing of lumbar puncture and cranial imaging is extracted from the electronic records at the departments of biochemistry or radiology while timing of antibiotic therapy for meningitis is identified in electronic medication systems. Time to lumbar puncture, cranial imaging and antibiotic therapy is calculated as time from arrival at hospital to each of the above events.

Quality control of case enrollment is ensured by ad hoc case-to-case discussions and at study group meetings 2-3 times a year

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence

时间窗: One year

Incidence of CNS infections in the adult population (\>17 years of age) in Denmark.

次要结局

  • Glasgow Outcome Scale score for encephalitis(30 days)
  • Glasgow Outcome Scale score for neuroborreliosis(2 weeks)
  • Glasgow Outcome Scale score for brain abscess(8 weeks)
  • Glasgow Outcome Scale score(One month after end of treatment)
  • Glasgow Outcome Scale score for viral meningitis(30 days)
  • Glasgow Outcome Scale score for bacterial meningitis(30 days)
  • Glasgow Outcome Scale score for neurosyphilis(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Bodilsen

Doctor

Aalborg University Hospital

研究点 (8)

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