Post Pandemic Pneumococcal Carriage Among Children and Adults

Pneumococcal Carriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373328
• Other study ID #: STUDY00006081
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: University of Central Florida
• Contact: Amoy Fraser, PhD, CCRP, PMP
• Phone: 4072668742
• Email: amoy.fraser[@]ucf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Carriage

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	Merck Sharp & Dohme Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR.		22 months
Secondary	Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.		22 months
Secondary	Putative transmission networks between children and adult populations from online questionnaires.		22 months