Post Pandemic Pneumococcal Carriage Among Children and Adults

University of Central Florida

Status: Enrolling

Conditions: Pneumococcal Carriage

Study type: Observational

Funder types: Other

Identifiers

NCT06373328

STUDY00006081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 7+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

900 participants in 2 patient groups

Children

Description:

This is a non-interventional study with data collection online, chart review, and biospecimen collection (nasopharyngeal swab). The swab will then be used for biomarker discovery. Findings will be compared and analyzed between the children and adult groups.

Adults

Description:

This is a non-interventional study with data collection online, chart review, and biospecimen collection (nasopharyngeal swab). The swab will then be used for biomarker discovery. Findings will be compared and analyzed between the children and adult groups.