Clinical trial NCT06248983: Transmission Of Respiratory Tract microOrganisms In a School Environment
Official title: Transmission Of Respiratory Tract microOrganisms In a School Environment - the TORTOISE-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Transmission
Microbial Colonization
Viral Respiratory Tract Infection
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Spaarne Gasthuis
First posted: 2024-02-08
Enrollment: 56
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: There are 2 sets of eligibility criteria, one for participating children and one for participation teachers.

Children:

Inclusion Criteria:

* Within age-limit
* attending primary school

Exclusion Criteria:

* Insufficient proficiency of their parents in Dutch or English language

Teachers:

Inclusion Criteria:

* Adult teacher of participating primary school class

Exclusion Criteria:

* Insufficient proficiency in Dutch or English language

Primary outcomes:
measure: Classroom transmission- and colonization-rate of Streptococcus pneumoniae in young children.
timeFrame: 8 weeks
Secondary outcomes:
measure: Transmission and colonization rates of other URT pathogens in a classroom setting.
timeFrame: 8 weeks
measure: Nasal immune response in response to exposure, infection or colonization by URT microbes.
timeFrame: 8 weeks
measure: The relationship between clinical symptoms of RTI's, host immune responses, microbiome and URT pathogens.
timeFrame: 8 weeks
measure: pollen and bacterial presence (airobiome) in classroom environment via electrostatic dust fall collector and pollensniffer to differentiate between RTI and hay fever.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid-Hollend
Study officials:
References: