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Post Pandemic Pneumococcal Carriage Among Children and Adults

ConditionPneumococcal Carriage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorUniversity of Central Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

900 Participants
are grouped into 2 trial groups
Group A: Children
Group B: Adults

Trial outcomes

Primary outcomes

1

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

Time frame
22 months

Secondary outcomes

1

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

Time frame
22 months
2

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

Time frame
22 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Central Florida

Lead sponsor

Merck Sharp & Dohme Corporation

Collaborator

Source ClinicalTrials.gov
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