Post Pandemic Pneumococcal Carriage Among Children and Adults

NCT06373328 | Recruiting

• 1 other identifier: STUDY00006081
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Carriage

Keywords

Nasopharyngeal; Children; Pandemic; Genomic; Epidemiology; Pneumococcal Carriage; Streptococcus pneumoniae

Outcome Measures

Primary Outcomes (1)

• Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR.

  22 months

Secondary Outcomes (2)

• Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.

  22 months

• Putative transmission networks between children and adult populations from online questionnaires.

  22 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Florida: lead
• Merck Sharp & Dohme Corporation: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimens from participants of the study will be coded and de-identified by the clinical research coordinators and will be accompanied by corresponding clinical data collected at the time of biospecimen collection. De-identified biospecimens will be stored at -80°C indefinitely. Data received with the biospecimens and from the analyses generated in the study will be stored electronically on a dedicated password protected server at the Burnett School of Biomedical Sciences and accessed only through UCF computers. Access to this data will be limited to the research personnel involved in the analyses. Biospecimens will be accessed only by authorized personnel working in the PIs laboratory.

Study Officials

• Taj Azarian, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742; amoy.fraser@ucf.edu

Erica Martin, B.S.

CONTACT

4072668742; erica.martin@ucf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 18, 2024
• Study Start: June 12, 2024
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)