Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)
研究概览
简要总结
The relationship between RSV (human respiratory syncytial virus) infections and invasive infections or pneumonia caused by Streptococcus pneumoniae has been observed epidemiologically for several years. Few fundamental data exist to support the epidemiological relationship. This study will investigate the proportion of pneumococcal carriage in RSV-infected infants and noninfected infants (proportion, serotype profile).
详细描述
The relationship between RSV (human respiratory syncytial virus) infections and Streptococcus pneumoniae pneumonia has been suggested for many years based on a similar seasonal pattern and cohort studies, but it could not be confirmed due to the circulation of several viruses concurrently. The post-COVID-19 period was marked by a temporal association between RSV infections and invasive pneumococcal disease (and pneumonia) in children under five, highlighting the potential role of RSV in the dynamics of pneumococcal disease in infants.
Furthermore, the carriage rate of S. pneumoniae in infants under 2 years of age in healthy populations is described as around 25%. In the case of RSV infection, this rate rises to 50%. Some data from animal models have shown that RSV infection increases S. pneumoniae transmission within a group of individuals, partly explaining this difference. However, data remain limited, particularly in human samples, and further research is needed to better understand the role of the RSV-pneumococcal relationship in the occurrence of severe RSV infections (pneumonia) and invasive pneumococcal infections. This study will examine pneumococcal carriage in bronchiolitis in infants aged 6-18 months, through nasopharyngeal swabs from infants with bronchiolitis and healthy infants. Pneumococcal carriage rates and serotype profiles will be investigated.
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
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 6 months to 18 months inclusive
- •With bronchiolitis during RSV epidemic season (bronchiolitis group) or without evidence of RSV viral infection (healthy group)
- •No chronic illness
- •No history of bronchiolitis
- •Signed consent from parents or legal guardians
- •Patient affiliated to a social security scheme
排除标准
- •Chronic respiratory illness
- •Medical history of bronchiolitis or newborn asthma
- •Treatment with immunosuppressants
- •Patient on AME
结局指标
主要结局
nasopharyngeal carriage rate of Streptococcus pneumoniae (Sp)
时间窗: Inclusion
Comparison of nasopharyngeal carriage rates of Streptococcus pneumoniae (Sp) in healthy infants and infants with RSV bronchiolitis.
次要结局
- serotype profile(Inclusion)
- proportion of 13-valent and 23-valent vaccine serotypes(Inclusion)
- proportion of non-vaccine serotypes(Inclusion)
- Serotype profile distribution(Inclusion)