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RecruitingNCT06373328Updated Dec 6, 2024

Post Pandemic Pneumococcal Carriage Among Children and Adults

An observational study in Pneumococcal Carriage, sponsored by University of Central Florida. Recruiting at 1 site in United States. Open to participants aged 7 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Central Florida · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
900
Ages
7 Months and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pneumococcal Carriage

Keywords

  • Nasopharyngeal
  • Children
  • Pandemic
  • Genomic
  • Epidemiology
  • Pneumococcal Carriage
  • Streptococcus pneumoniae
03

In context

Lead sponsor

University of Central Florida is the lead sponsor of 99 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The PI seeks to recruit 450 children 7-59 months of age and 450 adults 50 years or older over a 16-month period. Children will be equally distributed between 7-23 months and 24-59 months and adults equally distributed in the age ranges: 50-64 years, 65-74 years, and 75 years or older.

Pregnant women may choose to be in the study. The study procedures do not pose a risk to the safety of the unborn child or the woman.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
900 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Children

    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

    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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • University of Central Florida
    Orlando, Florida 32827, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06373328
Lead sponsor
University of Central Florida
Collaborators
Merck Sharp & Dohme Corporation
Responsible party
Sponsor
First posted
Apr 18, 2024
Start date
Jun 12, 2024
Primary completion
Sep 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Dec 6, 2024

Study contacts

Amoy Fraser, PhD, CCRP, PMP
Contact
amoy.fraser@ucf.edu
4072668742
Erica Martin, B.S.
Contact
erica.martin@ucf.edu
4072668742
Taj Azarian, PhD
principal investigator · University of Central Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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