Clinical trial NCT06373328: Post Pandemic Pneumococcal Carriage Among Children and Adults
Official title: Post-Pandemic Genomic Epidemiology of Pneumococcal Carriage Among Children and Adults in the General US Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumococcal Carriage
Keywords: Nasopharyngeal
Children
Pandemic
Genomic
Epidemiology
Pneumococcal Carriage
Streptococcus pneumoniae
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme Corporation
First posted: 2024-04-18
Enrollment: 900
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR.
timeFrame: 22 months
Secondary outcomes:
measure: Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.
timeFrame: 22 months
measure: Putative transmission networks between children and adult populations from online questionnaires.
timeFrame: 22 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Taj Azarian, PhD
role: PRINCIPAL_INVESTIGATOR
References: