Observatory of Nasopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis and in Healthy Child - Ancillary Study for Detection of E Coli ESBL Carriers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 23,560
- 试验地点
- 1
- 主要终点
- S. Pneumoniae colonisation to detect emerging serotypes
研究概览
简要总结
This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.
详细描述
Since September 2001, 121 pediatricians who are part of a research and teaching network (ACTIV) throughout France participated at this prospective study. From October to June of each subsequent year, children of both sexes suffering from suppurative acute otitis media (AOM) with fever and/or otalgia (in order to increase the probability of pneumococcal AOM), aged 6 to 24 months, were enrolled.
And a second group of healthy children aged 6 months to 15 years were also enrolled for the main study.
For ancillary study a subgroup of children were enrolled for assessment of E. coli (ESBL) resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both sexes
- •suffering from suppurative AOM
- •age: 6 months to 24 months for AOM
- •age: 6 months to 15 years for healthy children
- •informed consent from parents or guardians
排除标准
- •Children with antibiotic treatment within 7 days before enrolment,
- •severe underlying disease,
- •inclusion in the study during the previous 12 months
结局指标
主要结局
S. Pneumoniae colonisation to detect emerging serotypes
时间窗: at inclusion
The percentage of children colonised by non vaccine serotypes -
次要结局
- Detect the emergence of new serotypes(at inclusion)
- For the ancillary study, the resistance of E. coli (ESBL) will be evaluated.(at inclusion)
- Detect the emergence of resistance S. pneumoniae(at inclusion)
- Evaluation of the rhinopharyngeal carriage of other bacteria(at inclusion)