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Post Pandemic Pneumococcal Carriage Among Children and Adults

NCT ID: NCT06373328

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Pneumococcal Carriage

Keywords

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Nasopharyngeal Children Pandemic Genomic Epidemiology Pneumococcal Carriage Streptococcus pneumoniae

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme Corporation

UNKNOWN

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taj Azarian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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University of Central Florida

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amoy Fraser, PhD, CCRP, PMP

Role: CONTACT

Phone: 4072668742

Email: [email protected]

Erica Martin, B.S.

Role: CONTACT

Phone: 4072668742

Email: [email protected]

Facility Contacts

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Amoy Fraser, PhD, CCRP, PMP

Role: primary

Britney-Ann Wray, BS, CCRP, CTBS

Role: backup

Other Identifiers

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STUDY00006081

Identifier Type: -

Identifier Source: org_study_id