respiratory tract infections
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Children between the age of 4 and 7 years old or adult teacher attending the class
Exclusion criteria
Exclusion criteria: Insufficient proficiency of parents in Dutch or English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameter To answer the primary objective we will record Spn 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters Presence, transmission and/or introduction of common URT commensals/pathogens will be recorded and lead to categorical variables similar to the primary study parameter. Subtyping/sequencing will be performed where deemed relevant (rhinovirus, influenza virus etc.) to elude the source to the extent possible. Local host immune response in response to colonization/infection of URT by pathogens and potential differences in response between different pathogens will be measured using tools as ELISA or multiplex technologies, such as Olink and Luminex. We will focus on innate and adaptive inflammatory markers. We will also measure antibodies against pathogens using tools as ELISA and antigen arrays. The microbiome will be measured by 16S ribosomal RNA sequencing. Microbial products will be measured by tools like mass spectrometry. Clinical symptoms of RTI*s will be recorded in categorical variables (yes/no). To measure pollen (counts and species) and microbial presence in classroom environment via EDC and active air sampling (pollensniffer). Other study parameters Potentially relevant variables for colonization/infection, symptoms and host responses will be recorded in a questionnaire. This includes things like age and sex, history of respiratory infections, vaccination history, numbers and age of siblings, school/pre-school attendance, smoking status of parents, swimming pool visits. These will be used for exploratory purposes or as covariates in models. | — |
Countries
Netherlands
Outcome results
None listed