Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth/Herpangina Associated With Enteroviruses in Pediatric Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Prevalence of different types of Enteroviruses
研究概览
简要总结
The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :
- to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
- to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV.
详细描述
Any child presenting signs suggestive of HFMD/Herpangina can be included in the study by one of the investigating paediatricians. After giving the information note to the parents (and to children over 3 years of age) and asking them not to object, the paediatrician collects a throat or mouth swab to confirm the enterovirus infection. At the same time as the swab is taken, anonymised demographic and clinical data are collected by the doctor during the consultation. The sample and the information sheet are sent to the National Reference Laboratory for enteroviruses (Clermont-Ferrand University Hospital).The diagnosis is performed by EV genome detection and if positive, genotyping is done to identify the type of the enteroviruses.
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
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0 to 10 years presenting with HFMD or herpangina
排除标准
- •Refusal to participate by holders of parental authority
- •Refusal to participate for children over 3 years of age
结局指标
主要结局
Prevalence of different types of Enteroviruses
时间窗: 5 years
Prevalence of different types of enteroviruses associated with HFMD/Herpangina, determined by genomic detection of an enterovirus in samples sent to the National Reference Laboratory for enteroviruses. This will be carried out on a throat or mouth swab taken from a child seen in consultation for HFMD or herpangina at the time of the patient's inclusion in the study. Genomic detection will be carried out using real-time Reverse Transcription-Polymerase Chain Reaction, the reference method for diagnosing enterovirus infections. The type of enterovirus will then be identified by genotyping the sequence encoding the structural proteins or sequencing the complete enterovirus genome.
次要结局
- Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses(5 years)