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临床试验/NCT03983616
NCT03983616已完成不适用

Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 1,560 人开始时间: 2014年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,560
试验地点
2
主要终点
Frequency of invasive pneumococcal infections

研究概览

简要总结

Given the frequency and severity of invasive pneumococcal infections and questions about the place of VPC-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (IPI) cases. In particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the IPI in particular, their serotype. The follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult VPC-13 and to monitor the effects of VPC-13 vaccination recommendations. These effects are indirect, linked to the effect of vaccination of children with VPC-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the Vaccination Technical Committee of the High Council of Public Health). The project is based on the existing network of 23 Regional Pneumococcal Observatories (ORP) located in metropolitan France and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the ORP. Given the establishment in 2012 of an adult bacterial meningitis observatory, to which the ORP are associated, this project does not include the surveillance of pneumococcal meningitis in adults.

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

  • 18 years old patients or older hospitalized with invasive pneumococcal infection confirmed by isolation of a strain from a usually sterile site: blood or pleural fluid

排除标准

  • Pneumococcal meningitis identified by pneumococcal isolation or pneumococcal positive polymerase chain reaction (PCR) in cerebrospinal fluid

结局指标

主要结局

Frequency of invasive pneumococcal infections

时间窗: Day 0

identify the frequency of invasive pneumococcal infections in function of the presence of risk factors

次要结局

  • Number of Invasive Pneumococcal Infections in Adults(Day 0)
  • Weight of invasive pneumococcal infections(Day 0)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

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