Post Pandemic Pneumococcal Carriage Among Children and Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pneumococcal Carriage. Basic parameters: from 7 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Pandemic Genomic Epidemiology of Pneumococcal Carriage Among Children and Adults in the General US Population
Overview
The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas.
Detailed description
The SARS-CoV-2 pandemic profoundly impacted human health directly and indirectly. As such, elucidating pre- and post-pandemic trends in the epidemiology and population genomics of human respiratory pathogens including those such as the bacteria Streptococcus pneumoniae, a human commensal and the causative agent of invasive pneumococcal disease (IPD), merits study.
Nasopharyngeal samples will be processed at the PIs Laboratory to identify S. pneumoniae. If present, the isolate will undergo bacterial whole genome sequencings and population dynamic analysis. Carriage prevalence and serotype composition will be compared to extant studies and pneumococcal genomic data will be analyzed in the context of samples from the US and abroad.
Primary outcome measures
- Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR. [Time frame: 22 months]
Secondary outcome measures (2)
- Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries. [Time frame: 22 months]
- Putative transmission networks between children and adult populations from online questionnaires. [Time frame: 22 months]
Eligibility criteria
Inclusion criteria
- Children, ages 7 to 59 months (less than 5 years)
- Adults, ages 50 and older
- Ability to provide informed consent (from parents for children participants)
- ability to read and speak in English
- Agree to comply with study procedures (complete online data questionnaire and provide a nasopharyngeal collection).
Exclusion criteria
- Have been on an antibiotic in the last 2 weeks
- Have a respiratory infection that would make an nasopharyngeal collection improbable
- Have underlying developmental or chronic conditions impacting immune or respiratory function (e.g., immunocompromised, cystic fibrosis, cerebral palsy, paralysis)
- Adults unable to consent, individuals who are not yet adults, and prisoners will be excluded from this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- University of Central Florida — Orlando
Identifiers
NCT: NCT06373328 · STUDY00006081