Post Pandemic Pneumococcal Carriage Among Children and Adults

Recruiting

• Conditions: Pneumococcal Carriage

• Registration Number: NCT06373328
• Lead Sponsor: University of Central Florida

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.

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-06-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States