Post Pandemic Pneumococcal Carriage Among Children and Adults

Post-Pandemic Genomic Epidemiology of Pneumococcal Carriage Among Children and Adults in the General US Population

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06373328

Enrollment

900

Registered

2024-04-18

Start date

2024-06-12

Completion date

2026-03-31

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Carriage

Keywords

Nasopharyngeal, Children, Pandemic, Genomic, Epidemiology, Pneumococcal Carriage, Streptococcus pneumoniae

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

7 Months to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR.	22 months

Secondary

Measure	Time frame
Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.	22 months
Putative transmission networks between children and adult populations from online questionnaires.	22 months

Countries

United States

Contacts

Primary ContactAmoy Fraser, PhD, CCRP, PMP

amoy.fraser@ucf.edu4072668742

Backup ContactErica Martin, B.S.

erica.martin@ucf.edu4072668742

Outcome results