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Recruiting

NCT Number: NCT06373328

Post Pandemic Pneumococcal Carriage Among Children and Adults

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.

Recruiting

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Key information

Age range

7 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.

    Time frame: 22 months

  2. Putative transmission networks between children and adult populations from online questionnaires.

    Time frame: 22 months

Study contacts

Contact information is provided by the study sponsor or research team.

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Erica Martin, B.S.

CONTACT

[email protected]

4072668742

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Merck Sharp & Dohme Corporation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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