Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06049537
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2023-08-31
Brief Title:
Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal Sampling
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal Sampling
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAMSAM
Brief 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 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 infectionscolonization 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 infectioncolonisation 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 studytotal 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 infectioncolonisation Presence and load for bacteria and viruses in children in SAM versus saliva and NPS Local microbiota and immune profiles and association with infectioncolonisation and symptomology For a subset of parents daily presence and load of bacteria and viruses as well as host immune factors measured in saliva
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 infectioncolonisation 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 studytotal 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 infectioncolonisation Presence and load for bacteria and viruses in children in SAM versus saliva and NPS Local microbiota and immune profiles and association with infectioncolonisation 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None