Transmission Of Respiratory Tract microOrganisms In a School Environment

NCT ID: NCT06248983

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2024-04-26

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.

Detailed Description

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

Observational study, therefore no intervention that is administered.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Within age-limit
• attending primary school

• Adult teacher of participating primary school class

Exclusion Criteria

• Insufficient proficiency of their parents in Dutch or English language

Teachers:

• Insufficient proficiency in Dutch or English language

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaarne Gasthuis

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Simon P Jochems, PhD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spaarne Gasthuis

Hoofddorp, North Holland, Netherlands

Leiden University Medical Centre

Leiden, Zuid-Hollend, Netherlands

Countries

Netherlands

Other Identifiers

NL85480.058.23

Identifier Type: REGISTRY

Identifier Source: secondary_id

P23.094

Identifier Type: -

Identifier Source: org_study_id