An Observational Study to Estimate the Disease Burden of Rotavirus Gastroenteritis in Infants/Children Less Than Five Years of Age in Primary Care Settings, in Bulgaria and Latvia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,266
- 试验地点
- 1
- 主要终点
- Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.
研究概览
简要总结
This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.
详细描述
A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians.
Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for AGE treatment during the study period.
- •A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday.
- •Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject.
- •Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol.
排除标准
- •Child in care.
结局指标
主要结局
Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.
时间窗: At the time of enrollment of each subject (Day 0).
次要结局
- Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.(Day 0 - Day 14+5 (At the time of phone call follow-up contact).)
- Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.(At the time of enrollment of each subject (Day 0).)
- Number of hospitalisations for RV GE and AGE, reported at the primary care settings.(At the time of phone call follow-up contact (14 to 19 days after enrollment).)