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临床试验/NCT03237299
NCT03237299已完成不适用

Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2019年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
289
试验地点
1
主要终点
Frequency of exposure of interest

研究概览

简要总结

To study the association between several exposures of interest and the occurrence of infectious loco-regional complications of pharyngitis in children.

详细描述

Investigators will include in the study (after agreement of child and parents):

  • Cases: children < 18 years old hospitalized for peripharyngeal suppurations, diffuse cervical cellulitis or cervical adenophlegmon in participating Ear, Nose & Throat (ENT) and pediatric departments.
  • Controls: children < 18 years old with pharyngitis but without infectious complications recruited by general practitioners (GPs) or by primary care pediatricians in private setting, matched to cases by age, date of infectious complication (index date), delay between the pharyngitis and the index date and, if possible, the referring physician.

Primary endpoint: Difference in the frequency of exposure to various factors among cases and controls during an exposure window going from the date of diagnosis of pharyngitis to day -0.5 of the index date of the complication.

Several exposure of interest will be compared between cases and controls. One specific main exposure of interest during a predefined window of exposure has been defined but will not be revealed to investigators to avoid selection bias. Several secondary exposure of interest were a priori defined but will not be revealed to investigators to avoid selection bias.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Cases: children < 18 years old hospitalized for peripharyngeal suppurations, diffuse cervical cellulitis or cervical adenophlegmon in participating Ear, Nose & Throat (ENT) and pediatric departments.
  • Controls: children < 18 years old with pharyngitis but without infectious complications recruited by general practitioners (GPs) or by primary care pediatricians in private setting, matched to cases by age, date of infectious complication (index date), delay between the pharyngitis and the index date and, if possible, the referring physician.

排除标准

  • Children (cases or controls) with chronic renal failure, hemophilia, chronic thrombocytopenia or immunosuppression (constitutional or iatrogenic) at the time of pharyngitis

结局指标

主要结局

Frequency of exposure of interest

时间窗: from the date of diagnosis of pharyngitis up to 6 weeks

次要结局

  • Magnitude of the exposure of interest(from the date of diagnosis of pharyngitis up to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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