Transmission Of Respiratory Tract microOrganisms In a School Environment

NCT06248983 | Completed

• 2 other identifiers: P23.094NL85480.058.23
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Respiratory Tract Infections; Transmission; Microbial Colonization; Viral Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Classroom transmission- and colonization-rate of Streptococcus pneumoniae in young children.

  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.

  8 weeks

Secondary Outcomes (4)

• Transmission and colonization rates of other URT pathogens in a classroom setting.

  8 weeks

• Nasal immune response in response to exposure, infection or colonization by URT microbes.

  8 weeks

• The relationship between clinical symptoms of RTI's, host immune responses, microbiome and URT pathogens.

  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

Study Arms (1)

Participants

Observational study, therefore no intervention that is administered.

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children attending primary school, age 4-7 (year 1-2 of primary education) and their teachers. The investigators aim to include minimal 80% of children in a given class. In total the investigators aim to include three classes within one season.

You may qualify if:

• Within age-limit
• attending primary school

You may not qualify if:

• Insufficient proficiency of their parents in Dutch or English language
• Teachers:
• Adult teacher of participating primary school class
• Insufficient proficiency in Dutch or English language

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Spaarne Gasthuis: collaborator

Study Sites (2)

Spaarne Gasthuis

Hoofddorp, North Holland, 2134TM, Netherlands

Location

Leiden University Medical Centre

Leiden, Zuid-Hollend, 2333 ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal epithelial lining fluid will be sampled using a nasosorption device

MeSH Terms

Conditions

Respiratory Tract Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: February 26, 2024
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)