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临床试验/NCT04184336
NCT04184336Unknown不适用

IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada

Canadian Paediatric Society13 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
13
主要终点
Laboratory confirmed invasive meningococcal cases.

研究概览

简要总结

Active metropolitan area surveillance for hospital admissions related to invasive infection with Neisseria meningitidis will be conducted at the 12 centers in the IMPACT network in collaboration with Public Health officials, local infection specialists and infection control practitioners during the interval from January 1, 2016 to December 31, 2022.

详细描述

The objectives are 3-fold, including:

  1. description of affected children and adults and the nature and outcome of the infection episodes
  2. incidence rate determination in defined populations, by age, serogroup and study year
  3. detailed study of the organisms recovered from cases

研究设计

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

入排标准

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

入选标准

  • Neisseria meningitidis isolated or detected by PCR from a normally sterile body site or fluid, such as blood, CSF, joint fluid, pleural, peritoneal, pericardial fluid or tissue biopsy -

排除标准

  • patients diagnosed based only on
  • clinical signs, gram stain, or antigen test
  • meningococci isolated only from respiratory tract, including conjunctiva, sinuses, middle ear/mastoid, throat, peritonsillar abscess, cervical lymph node, tracheal aspirate, bronchial lavage etc -

结局指标

主要结局

Laboratory confirmed invasive meningococcal cases.

时间窗: End of 2021

Laboratory confirmed invasive meningococcal cases.

次要结局

未报告次要终点

研究者

发起方
Canadian Paediatric Society
申办方类型
Other
责任方
Sponsor

研究点 (13)

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