Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,900
- 试验地点
- 1
- 主要终点
- Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics
研究概览
简要总结
Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)
详细描述
The study protocol is designed with three key components: 1. Build on existing PARI outpatient syndromic surveillance by adding laboratory multiplex testing of LRTI samples (RSV, Influenza, SARS-COV-2) 2. Follow all bronchiolitis through the PARI RWE database and document "patient journey" for 5 years after first medical visit 3. Review the electronic PARI data of three previous seasons in order to document the impact of LRTI attributable to RSV in children < 2 years in France prior to enhanced surveillance
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children under 24 months of age (≤)
- •One of the holders of parental authority signed the consent
- •Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)
- •Acute purulent otitis media (Paradise Criteria) or otorrhea with or withitout associated bronchiolitis
排除标准
- •Age >24 months
- •Refusal by one of the parents
- •Not affiliated to a social security system
- •Maternal RSV vaccination during the pregnancy of the included child
研究组 & 干预措施
Otitis associated with Bronchiolitis
Only for city physicians:
800 children presenting with acute otitis media associated with bronchiolitis will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.
干预措施: nasopharyngeal samples (Diagnostic Test)
Otitis not associated with Bronchiolitis
Only for city physicians:
A total of 1,100 children presenting with acute otitis media, without concomitant bronchiolitis, will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.
干预措施: nasopharyngeal samples (Diagnostic Test)
结局指标
主要结局
Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics
时间窗: day of enrollment
Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV)
次要结局
- Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings(day of enrollment)
- Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients(day of enrollment)
- Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings(day of enrollment)
- Patient care pathway documentation(day of enrollment, at days 15 and at 6 months after inclusion)
- Score of Quality of life(15 days and 6 months after inclusion)
- Socioeconomic impact: Parental work absenteeism(15 days and 6 months after inclusion)
- Demographic and clinical characteristics of included children(day of enrollment)