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临床试验/NCT05274607
NCT05274607招募中不适用

French Epidemiological Pediatric Study on Pneumonia and Empyema in Emergency Departments in Children 1 Month to 15 Years

Association Clinique Thérapeutique Infantile du val de Marne1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20,000
试验地点
1
主要终点
Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion

研究概览

简要总结

Describe the epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: frequency, clinical and biological characteristics, responsible bacteria and pneumococcus place, antibiotic resistance, treatment, vaccine status.

详细描述

The pneumonia observatory began in June 2009 and has included more than 15,000 children with pneumonia or pneumonia with pleural effusion (hospitalized or not) until May 2019. This study led to the publication of many articles in international peer-reviewed journals. Since June 2019, the scientific committee of the study met at the ESPID congress has decided to include only hospitalized patients. This amendment is justified for three reasons:

  • Change in criteria for diagnosing pneumonia with increasing use of chest ultrasound
  • Logistical aspects and workload of investigating centers too important
  • Long-term impact of pneumococcal vaccine 13-valent especially marked for the most severe cases In this context, the purpose of this amended study is to enroll only the most severe cases of pneumonia, i.e. requiring hospitalization, in ICU or not. Since this study began in 2009, we have already enrolled hospitalized cases, we will have a baseline prior to the introduction of third-generation PCVs (pneumococcal conjugate vaccines) and we will be able to continue monitoring with data since 2009.

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
1 Month 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ages between 1 month and 15 years
  • presence of parenchymatous condensation and/or pleural effusion on chest x-rays and/or ultrasounds and/or CT scans
  • fever ≥38.5 °C if age ≥3 months since the onset of symptoms or ≥38 °C if the child is less than 3 months old.
  • Hospitalization

排除标准

  • Refusal of participation by the patient, his or her relative or legal representative (depending on the situation)

结局指标

主要结局

Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion

时间窗: 15 years

- Describe the epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: frequency, clinical and biological characteristics, responsible bacteria and pneumococcus place, antibiotic resistance, treatment, vaccine status.

次要结局

  • Impact of pneumococcal conjugate vaccines(15 years)
  • Treatments(15 years)

研究者

发起方
Association Clinique Thérapeutique Infantile du val de Marne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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