Virus Interactions in the Respiratory Tract; a Cohort Study With Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Strength of viral interactions
研究概览
简要总结
Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children.
Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children.
Study design: This is a prospective observational cohort study.
Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands.
Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis.
Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
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
- 6 Weeks 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 6 weeks and 4 years AND
- •have older siblings or 2) attend daycare. AND
- •Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored
排除标准
- •recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR
- •known immunodeficiency OR
- •chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR
- •congenital anomalies of the airways
- •Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language)
结局指标
主要结局
Strength of viral interactions
时间窗: Samples and data collected during 16 weeks of follow-up
To quantify the strength of interactions between common respiratory virus infections in young children.
Direction of viral interactions
时间窗: Samples and data collected during 16 weeks of follow-up
To quantify the direction of interactions between common respiratory virus
次要结局
- To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.(Samples and data collected during 16 weeks of follow-up)
- To quantify the changes in viral exposure in the pandemic-to-post-pandemic transition period and study effects of these changes on viral interaction patterns(Samples and data collected during 16 weeks of follow-up)
- To quantify relative change in disease severity due to viral interactions.(Samples and data collected during 16 weeks of follow-up)
- To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children(Samples and data collected during 16 weeks of follow-up)
研究者
Patricia Bruijning-Verhagen
Principal investigator
UMC Utrecht