Respiratory Tract InfectionsTORTOISENCT06248983
Transmission Of Respiratory Tract microOrganisms In a School Environment
An observational study of Respiratory Tract Infections and Transmission, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Transmission, Microbial Colonization
- How many people
- 56 participants
- Where
- 2 sitesNetherlands
- Study dates
- 26 Feb 2024to 26 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Within age-limit
- attending primary school
- Adult teacher of participating primary school class
Who cannot join
- Insufficient proficiency of their parents in Dutch or English language
- Teachers:
- Insufficient proficiency in Dutch or English language
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Spaarne Gasthuis
Hoofddorp, North Holland, 2134TM
Leiden University Medical Centre
Leiden, Zuid-Hollend, 2333 ZA
About this study
Official title: Transmission Of Respiratory Tract microOrganisms In a School Environment - the TORTOISE-study
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.
Read the 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
- Medical subject headings
- Respiratory Tract Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Observational study, therefore no intervention that is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Transmission and colonization rates of other URT pathogens in a classroom setting.
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.
Measured: 8 weeks
Nasal immune response in response to exposure, infection or colonization by URT microbes.
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. The investigators will focus on innate and adaptive inflammatory markers. The investigators will also measure antibodies against pathogens using tools as ELISA and antigen arrays.
Measured: 8 weeks
The relationship between clinical symptoms of RTI's, host immune responses, microbiome and URT pathogens.
Clinical symptoms of RTI's will be recorded in categorical variables (yes/no).The microbiome will be measured by RNA sequencing. Microbial products will be measured by tools like mass spectrometry.
Measured: 8 weeks
pollen and bacterial presence (airobiome) in classroom environment via electrostatic dust fall collector and pollensniffer to differentiate between RTI and hay fever.
Pollen (counts and species) and microbial presence in classroom environment will be measured via Electrostatic Dust Collector and active air sampling using a pollensniffer.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start26 Feb 2024
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Spaarne Gasthuis
- Responsible party
- Principal investigator, Simon P Jochems, PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248983
- Sponsor's protocol ID
- P23.094
- Other IDs
- NL85480.058.23
- Acronym
- TORTOISE
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission Of Respiratory Tract microOrganisms In a School Environment - the TORTOISE-study
- ClinicalTrials.gov ID
- NCT06248983
- Acronym / sponsor ID
- TORTOISE / P23.094
- Conditions
- Respiratory Tract Infections, Transmission, Microbial Colonization, Viral Respiratory Tract Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Spaarne Gasthuis
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Observational study, therefore no intervention that is administered. |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Within age-limit
- attending primary school
- Adult teacher of participating primary school class
Key exclusion criteria (3 listed)
- Insufficient proficiency of their parents in Dutch or English language
- Insufficient proficiency in Dutch or English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classroom transmission- and colonization-rate of Streptococcus pneumoniae in young children.
Time frame: 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.
4 secondary outcomes
Transmission and colonization rates of other URT pathogens in a classroom setting.
Time frame: 8 weeks
Nasal immune response in response to exposure, infection or colonization by URT microbes.
Time frame: 8 weeks
The relationship between clinical symptoms of RTI's, host immune responses, microbiome and URT pathogens.
Time frame: 8 weeks
pollen and bacterial presence (airobiome) in classroom environment via electrostatic dust fall collector and pollensniffer to differentiate between RTI and hay fever.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Transmission, run by Leiden University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classroom transmission- and colonization-rate of Streptococcus pneumoniae in young children. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.