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临床试验/NCT04807660
NCT04807660招募中不适用

Bacteriological Evaluation of Spontaneous Otorrhea in Children

Association Clinique Thérapeutique Infantile du val de Marne1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2015年10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
1,500
试验地点
1
主要终点
Bacteria identification

研究概览

简要总结

After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.

详细描述

Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 41 pediatricians who are part of a research and teaching network (ACTIV, Association Clinique et Thérapeutique Infantile du Val de Marne [Clinical and Therapeutic Association of Val de Marne]) throughout France. For some patients, otorrhea is the first manifestation of AOM; for others, otorrhea occurred after AOM treatment failure or recurrence. Failure (non-responsive AOM) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. Recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for AOM.

Middle ear fluid (MEF) is obtained by sampling spontaneous discharge according to clinical practice guidelines. MEF specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (Copan Venturi Transystem®, Brescia, Italy), and transported within 48 hr to one of the two centralized microbiology laboratories (Robert Debré Hospital or National Centre for Pneumococci at European Georges Pompidou Hospital, Paris, France).

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
3 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children from 3 months to 15 years old
  • with otorrhea
  • signed parents consent

排除标准

  • children under 3 months
  • children > 15 years old

结局指标

主要结局

Bacteria identification

时间窗: at inclusion

The percentage of children with otopathogens

次要结局

  • Describe the serotypes of S. pneumoniae(at inclusion)
  • Describe the resistance of heamophilus influenzae(at inclusion)

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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