Respiratory Tract; Infection, Upper (Acute)SAMSAMNCT06049537
Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal Sampling
An observational study of Respiratory Tract; Infection, Upper (Acute) and Colonization, Asymptomatic, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Respiratory tract infections (RTI) are a major cause of morbidity in young children in high- income countries and the major cause of mortality in developing countries. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Respiratory Tract; Infection, Upper (Acute), Colonization, Asymptomatic
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jan 2022to 27 Nov 2023
- 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 1 year to 5 years
- All sexes
- Child
Study population: Children aged 1-6 years old, as these are a main population at risk for severe respiratory tract infections, and a main source of transmission. The study team will recruit families from the area of North/South-Holland as this will facilitate the home visits.
Who may be able to join
- Written informed consent obtained from all legal representatives, for example both parents.
- Child aged 1-5 years of age attending day care, peuterspeelzaal or school at least 2 (half) days a week.
- Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples. This does not include donation of saliva by parents themselves, which is related to a secondary endpoint.
Who cannot join
- History of respiratory tract infections requiring hospitalization
- Current use of antibiotics, or antibiotics use in past four weeks
- Use of immune-altering medication (such as steroids, including inhaled corticosteroid)
- No history of severe concomitant disease (severe congenital heart disease, bronchopulmonary dysplasia, prematurity <32 weeks, cystic fibrosis, sickle cell disease, congenital or acquired immunodeficiency disorders, cardiovascular disease, neuromuscular disorders, oncology patients or major congenital anomalies)
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Respiratory tract infections (RTI) are a major cause of morbidity in young children in high- income countries and the major cause of mortality in developing countries. Causative bacteria and viruses are regular residents of the nasopharynx of asymptomatic individuals (colonization) and live there together with other presumed harmless commensals, without causing disease. These non-pathological infections/colonization episodes are important for transmission, intermediate step to disease and boost immune responses. The investigators recently validated the use of minimally-invasive nasal sampling methods that can be done at home for the study of host and microbial parameters in adults and children. In this study the investigators will focus on the daily microbial and immunological composition of the nasopharynx during health in relation to symptoms.
Primary objective: Associate acquisition of pneumococcal colonisation with levels of pre-existing polysaccharide specific memory B cells.
Read more
Secondary objectives include: Validate the use of synthetic absorptive matrices (SAM) for detection of respiratory pathogens versus nasopharyngeal swabs (NPS) and saliva; Assess dynamics of URT infection/colonisation and examine its relationship with symptoms, host responses and microbiota; Measure transmission between children and parents and immune responses in parents.
Study design: Prospective community-based cohort study.total of 45 children, aged 1-5 years old attending daycare or (pre-)school, will be included, including a pilot of 10 children to assess tolerability. If there are insufficient pneumococcal acquisitions in the study to assess the primary outcome, additional children can be recruited in groups of 3 or 4 children (up to 10). For a subset of participating children, both parents will be asked to self-collect daily saliva during the study.
Primary study parameters: Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised Secondary study parameters: Dynamics of respiratory bacteria and viruses during URT infection/colonisation. Presence and load for bacteria and viruses in children in SAM versus saliva and NPS. Local microbiota and immune profiles and association with infection/colonisation and symptomology. For a subset of parents, daily presence and load of bacteria and viruses as well as host immune factors measured in saliva.
- Keywords
- Host-pathogen interactions, Minimally-invasive nasal sampling, Colonization/URT infections in children
- Medical subject headings
- Infections, Asymptomatic Infections
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 |
|---|---|---|
| Young children | Children aged 1-5 years old attending school or day care. Follow-up for 28 days using minimally-invasive nasosorption sampling and questionnaires relating to symptoms. No intervention administered | |
| Parents | Parents of enrolled children, if it is a one-child family. Follow-up for 28 days using minimally-invasive saliva sampling. No intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised
Measured: up to study completion, 28 or 29 days
Secondary outcomes (11)
The number of participants with pneumococcal colonisation presence over time.
lyta, piab and serotype-specific qPCR
Measured: up to study completion, 28 or 29 days
Pneumococcal colonisation density over time.
lyta, piab and serotype-specific qPCR
Measured: up to study completion, 28 or 29 days
The number of participants with presence of other bacteria and viruses
Presence of other respiratory bacteria (such as Haemophilus influenzae and Staphylococcus aureus) and viruses (such as coronaviruses and influenza virus) during URT infection/colonisation, measured by molecular methods.
Measured: up to study completion, 28 or 29 days
Density of other bacteria and viruses
Density of other respiratory bacteria (such as Haemophilus influenzae and Staphylococcus aureus) and viruses (such as coronaviruses and influenza virus) during URT infection/colonisation, measured by molecular methods.
Measured: up to study completion, 28 or 29 days
Local microbiome composition measured by 16S
Relative abundance of ASV
Measured: up to study completion, 28 or 29 days
Nasal and systemic antibodies titres specific for identified pathogens, measured using ELISA or antigen arrays
antigen-specific IgG, IgA and IgM titres
Measured: up to study completion, 28 or 29 days
Nasal cytokine levels, assessed using multiplex assays such as Luminex
Individual cytokines will be reported in absolute or relative values
Measured: up to study completion, 28 or 29 days
Symptom questionnaires
Symptoms are scaled on presence/absence
Measured: up to study completion, 28 or 29 days
Evaluation/Sample tolerability questionnaires
scale includes completely disagree, disagree, neutral, agree, completely agree for each question
Measured: day 28, last visit
Presence of bacteria and viruses in saliva of a subset of parents on a daily interval
Measured using molecular methods
Measured: up to study completion, 28 or 29 days
Density of bacteria and viruses in saliva of a subset of parents on a daily interval
Measured using molecular methods
Measured: up to study completion, 28 or 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start21 Jan 2022
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract; Infection, Upper (Acute)Studies 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
- 46 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
- Investigators
- Marlies A van Houten, MD, Principal investigator, Spaarne Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049537
- Sponsor's protocol ID
- P21.067
- Acronym
- SAMSAM
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If any samples or data are shared to perform analyses as described in the study protocol, either inside or outside EU, only pseudonymized material is shared to ensure participant privacy. This can be done upon request and following the signing of MTA/DTA. Individual datasets might be placed on repositories with restricted access or fully anonymized (such as Zenodo or flowrepository.org) upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal Sampling
- ClinicalTrials.gov ID
- NCT06049537
- Acronym / sponsor ID
- SAMSAM / P21.067
- Keywords
- Host-pathogen interactions, Minimally-invasive nasal sampling, Colonization/URT infections in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Spaarne Gasthuis
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 22 Sep 2023 (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.
Rationale: Respiratory tract infections (RTI) are a major cause of morbidity in young children in high- income countries and the major cause of mortality in developing countries. Causative bacteria and viruses are regular residents of the nasopharynx of asymptomatic individuals (colonization) and live there together with other presumed harmless commensals, without causing disease. These non-pathological infections/colonization episodes are important for transmission, intermediate step to disease and boost immune responses. The investigators recently validated the use of minimally-invasive nasal sampling methods that can be done at home for the study of host and microbial parameters in adults and children. In this study the investigators will focus on the daily microbial and immunological composition of the nasopharynx during health in relation to symptoms.
Primary objective: Associate acquisition of pneumococcal colonisation with levels of pre-existing polysaccharide specific memory B cells.
Secondary objectives include: Validate the use of synthetic absorptive matrices (SAM) for detection of respiratory pathogens versus nasopharyngeal swabs (NPS) and saliva; Assess dynamics of URT infection/colonisation and examine its relationship with symptoms, host responses and microbiota; Measure transmission between children and parents and immune responses in parents.
Study design: Prospective community-based cohort study.total of 45 children, aged 1-5 years old attending daycare or (pre-)school, will be included, including a pilot of 10 children to assess tolerability. If there are insufficient pneumococcal acquisitions in the study to assess the primary outcome, additional children can be recruited in groups of 3 or 4 children (up to 10). For a subset of participating children, both parents will be asked to self-collect daily saliva during the study.
Primary study parameters: Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised Secondary study parameters: Dynamics of respiratory bacteria and viruses during URT infection/colonisation. Presence and load for bacteria and viruses in children in SAM versus saliva and NPS. Local microbiota and immune profiles and association with infection/colonisation and symptomology. For a subset of parents, daily presence and load of bacteria and viruses as well as host immune factors measured in saliva.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young children | – | –Children aged 1-5 years old attending school or day care. Follow-up for 28 days using minimally-invasive nasosorption sampling and questionnaires relating to symptoms. No intervention administered |
| Parents | – | –Parents of enrolled children, if it is a one-child family. Follow-up for 28 days using minimally-invasive saliva sampling. No intervention administered |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged 1-6 years old, as these are a main population at risk for severe respiratory tract infections, and a main source of transmission. The study team will recruit families from the area of North/South-Holland as this will facilitate the home visits.
Key inclusion criteria (3 listed)
- Written informed consent obtained from all legal representatives, for example both parents.
- Child aged 1-5 years of age attending day care, peuterspeelzaal or school at least 2 (half) days a week.
- Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples. This does not include donation of saliva by parents themselves, which is related to a secondary endpoint.
Key exclusion criteria (4 listed)
- History of respiratory tract infections requiring hospitalization
- Current use of antibiotics, or antibiotics use in past four weeks
- Use of immune-altering medication (such as steroids, including inhaled corticosteroid)
- No history of severe concomitant disease (severe congenital heart disease, bronchopulmonary dysplasia, prematurity <32 weeks, cystic fibrosis, sickle cell disease, congenital or acquired immunodeficiency disorders, cardiovascular disease, neuromuscular disorders, oncology patients or major congenital anomalies)
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
Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised
Time frame: up to study completion, 28 or 29 days
11 secondary outcomes
The number of participants with pneumococcal colonisation presence over time.
Time frame: up to study completion, 28 or 29 days
Pneumococcal colonisation density over time.
Time frame: up to study completion, 28 or 29 days
The number of participants with presence of other bacteria and viruses
Time frame: up to study completion, 28 or 29 days
Density of other bacteria and viruses
Time frame: up to study completion, 28 or 29 days
Local microbiome composition measured by 16S
Time frame: up to study completion, 28 or 29 days
Nasal and systemic antibodies titres specific for identified pathogens, measured using ELISA or antigen arrays
Time frame: up to study completion, 28 or 29 days
Nasal cytokine levels, assessed using multiplex assays such as Luminex
Time frame: up to study completion, 28 or 29 days
Symptom questionnaires
Time frame: up to study completion, 28 or 29 days
Evaluation/Sample tolerability questionnaires
Time frame: day 28, last visit
Presence of bacteria and viruses in saliva of a subset of parents on a daily interval
Time frame: up to study completion, 28 or 29 days
Density of bacteria and viruses in saliva of a subset of parents on a daily interval
Time frame: up to study completion, 28 or 29 days
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 12 Dec 2023.
- Individual participant dataSharing planned: Undecided. If any samples or data are shared to perform analyses as described in the study protocol, either inside or outside EU, only pseudonymized material is shared to ensure participant privacy. This can be done upon request and following the signing of MTA/DTA. Individual datasets might be placed on repositories with restricted access or fully anonymized (such as Zenodo or flowrepository.org) upon publication.
Related trials for Respiratory Tract; Infection, Upper (Acute)
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Recruiting
Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds
Acute Otitis Media (AOM), Upper Respiratory Infection
Not yet recruitingObservational study
Observational Study of SIROPSEDAL in Acute Cough
Acute Cough, Upper Respiratory Tract Infection
RecruitingObservational study
Potential of Interface Care Models to Deliver More Appropriate Care to Patients With Acute Medical Illness
Falls Injury, Falls
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.
Marlies A van Houten, MD principal investigator
Spaarne Gasthuis
1 site 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; Infection, Upper (Acute) and Colonization, Asymptomatic, run by Leiden University Medical Center at 1 site 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 4 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised (time frame: up to study completion, 28 or 29 days). 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 12 Dec 2023.