Actively Recruiting

Age: 7Months +
All Genders
Healthy Volunteers
ID06373328

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

Led by University of Central Florida · Updated on 2024-12-06

900

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

U

University of Central Florida

Lead Sponsor

M

Merck Sharp & Dohme Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the genetic patterns and spread of Streptococcus pneumoniae, a common bacteria linked to invasive pneumococcal disease, among children and adults in a large metropolitan area. This study aims to understand how the pandemic affected the presence and types of this bacteria by comparing samples collected before and after the SARS-CoV-2 pandemic. The study is observational and focuses on the population structure and relationships between bacterial samples from different age groups and geographic locations. Participants will provide nasopharyngeal swab samples, which will be analyzed in the laboratory to detect S. pneumoniae. If the bacteria are present, whole genome sequencing will be performed to study the bacterial population dynamics. The study will include groups of children and adults, with data collected through online questionnaires, chart reviews, and biospecimen collection. Findings will be compared between the two age groups and to data from other regions. During the study, participants complete online questionnaires and provide swab samples. The researchers will measure the prevalence of pneumococcal carriage and identify the types of bacteria using qPCR over 22 months. They will also analyze the genetic relationships between bacterial isolates and study transmission patterns between children and adults. Safety and compliance will be monitored, and participation includes follow-up assessments during the study period.

CONDITIONS

Brief Title

Post Pandemic Pneumococcal Carriage Among Children and Adults

Who Can Participate

Age: 7Months +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 7 to 59 months (less than 5 years)
  • Adults aged 50 years and older
  • Ability to provide informed consent (parents consent for children)
  • Ability to read and speak English
  • Agree to complete online questionnaire and provide nasopharyngeal sample
Not Eligible

You will not qualify if you...

  • Use of antibiotics within the last 2 weeks
  • Respiratory infection that prevents nasopharyngeal sample collection
  • Underlying developmental or chronic conditions affecting immune or respiratory function (e.g., immunocompromised, cystic fibrosis, cerebral palsy, paralysis)
  • Adults unable to consent, individuals under 18 years old, and prisoners

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online) to confirm eligibility and obtain consent

Sample Collection

Duration - Up to 22 months

Participants provide a nasopharyngeal swab sample and complete an online questionnaire to gather data on pneumococcal carriage and transmission.

1 visit for nasopharyngeal sample collection and online questionnaire completion

Long-term Monitoring

Duration - Up to 22 months

Data from sample analysis and questionnaires are monitored over time to understand pneumococcal carriage prevalence, serotype distribution, and transmission dynamics among children and adults.

No additional visits; monitoring occurs through data analysis

Trial Site Locations

Total: 1 location

1

University of Central Florida

Orlando, Florida, United States, 32827

Actively Recruiting

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Research Team

A

Amoy Fraser, PhD, CCRP, PMP

E

Erica Martin, B.S.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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