Pneumococcal Carriage Duration | NCT07748832

NCT07748832

Overview

NCT ID: NCT07748832
Lead Sponsor: University of Central FloridaOTHER
Official Title: NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study
Brief Summary: Streptococcus pneumoniae (SPN) remains a leading cause of respiratory disease in young children despite widespread vaccination. Understanding the duration of pneumococcal carriage, patterns of co-colonization, and the influence of viral infections and the respiratory microbiome is essential to evaluate next-generation pneumococcal vaccines and inform public health strategies. Current data on Streptococcus pneumoniae carriage dynamics are limited in U.S. pediatric populations. This study aims to generate updated estimates of Streptococcus pneumoniae colonization and explore microbial interactions using high-resolution longitudinal sampling and genomic methods.
Conditions: Pneumococcal Carriage

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Are older than 28 days and under 4 years of age at the time of enrollment.

Have a parent or legal guardian who:

Provides written informed consent.

Is able to read and speak English or Spanish.

Agrees to comply with all study procedures, including completion of questionnaires and biweekly oropharyngeal (OP) swab collections from the child for a period of 12 months.

Exclusion Criteria:

History of chronic medical conditions or immunocompromising conditions that may influence pneumococcal carriage or study participation, such as:

cystic fibrosis

cerebral palsy

neuromuscular disorders

congenital heart disease

known congenital or acquired immunodeficiencies

sickle cell disease

undergoing immunosuppressive therapy (e.g., systemic corticosteroids ≥2 mg/kg/day for ≥14 days, chemotherapy, biologics)

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