Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal Sampling
NCT ID: NCT06049537
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2022-01-21
2023-11-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
1 Year
5 Years
ALL
No
Sponsors
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Spaarne Gasthuis
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Simon P Jochems, PhD
assistant professor
Principal Investigators
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Marlies A van Houten, MD
Role: PRINCIPAL_INVESTIGATOR
Spaarne Gasthuis
Locations
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Spaarne Gasthuis
Hoofddorp, , Netherlands
Countries
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Other Identifiers
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P21.067
Identifier Type: -
Identifier Source: org_study_id