Transmission Of Respiratory Tract microOrganisms In a School Environment - the TORTOISE-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Classroom transmission- and colonization-rate of Streptococcus pneumoniae in young children.
研究概览
简要总结
Through contact with peers in daycare and (primary)school young children play a large role in spreading respiratory pathogens. In this study the investigators will investigate this transmission, the subsequent colonization and infection dynamics, and their association with clinical symptoms and local immune response through dense minimally-invasive sampling. This study will allow us a unique insight into the transmission-, infection-, and colonization-potential of the respiratory pathogens.
详细描述
Respiratory tract infections impose a large burden of disease upon the world. Pneumonia remains the leading infectious cause of death in children under five worldwide. Known causative agents of pneumonia include, but are not limited to, Spn, Haemophilus influenzae (HI), Moraxella catarrhalis (MC) and viruses such as the Respiratory Syncytial Virus (RSV) and the influenza virus. These microorganisms are regularly found in the upper respiratory tract (URT) without causing severe disease. Colonization of the URT is thought to be important both for immune boosting and to provide competition for other potential harmful colonizers.
This study aims to provide insights into the processes and key host immune and microbiota factors that determine the infection kinetics, transmission and development of immunity during such infections. Furthermore, this study will enable us to closely study the transmission of commonly found microorganisms in an environment that is prone to transmission, the close quarters of school classes in which young children and their teachers spend a large part of their time.
Research within this specific population (risk-group and high transmitting group), young children and their teachers, is warranted. This is due to differences in the pediatric and adult mucosal immune system and infection and transmission dynamics, while animal models not being directly translatable to the human situation.
In this study the investigators will perform dense, longitudinal sampling within groups of closely interacting children and their teachers to study spread and colonization. Furthermore, by determining a range of biomarkers along with profiling the respiratory microbiome the investigators can look for markers predicting colonization and symptomatic infection.
By measuring airobiome through the EDC and air samples collected by a pollensniffer the investigators can measure local exposure to environmental microbes, human pathogens and pollen. This will allow us to compare immune responses and correlate this with clinical symptoms of RTI.
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
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Within age-limit
- •attending primary school
排除标准
- •Insufficient proficiency of their parents in Dutch or English language
- •Inclusion Criteria:
- •Adult teacher of participating primary school class
- •Exclusion Criteria:
- •Insufficient proficiency in Dutch or English language
结局指标
主要结局
Classroom transmission- and colonization-rate of Streptococcus pneumoniae in young children.
时间窗: 8 weeks
To answer the primary objective the investigators will record pneumococcus carriage over time at a serotype level using qPCR. This will lead to a categorical variable with the following levels for each included serotype, per participant: never infected (no Spn detected during the sampling period), already colonized (Spn detected at the start of the sampling period), new colonization (Spn not detected at the start of the sampling period, but detected in the course of the sampling period) or re-colonization (same Spn serotype detected during sampling period with at least 3 samples in between not detecting Spn). A transmission event will be defined as a Spn serotype that is observed in at least one child in the class and at a later timepoint also observed in one or more other children, as long as this is within 1 week of it being present in first child.
次要结局
- Transmission and colonization rates of other URT pathogens in a classroom setting.(8 weeks)
- The relationship between clinical symptoms of RTI's, host immune responses, microbiome and URT pathogens.(8 weeks)
- Nasal immune response in response to exposure, infection or colonization by URT microbes.(8 weeks)
- pollen and bacterial presence (airobiome) in classroom environment via electrostatic dust fall collector and pollensniffer to differentiate between RTI and hay fever.(8 weeks)
研究者
Simon P Jochems, PhD
Associate professor
Leiden University Medical Center