Pneumococcal Carriage Duration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oropharyngeal (OP) swab.
- Who it may be relevant to
- Registry conditions: Pneumococcal Carriage. Basic parameters: 28 Days — 48 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study
Overview
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.
Interventions
- Other Oropharyngeal (OP) swab
At each study visit, a double-tipped OP swab will be collected by trained clinical research staff. All swabs will be collected using a standard protocol. There will be 26 total study visits over the course of one year.
Primary outcome measures
- Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years. [Time frame: One year]
- Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years. [Time frame: One year]
- Evaluate the feasibility and scalability of expanding the study to a larger sample size [Time frame: One year]
Secondary outcome measures (3)
- Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children [Time frame: One year]
- Assessment of study methodologies [Time frame: One year]
- To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history. [Time frame: One year]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Central Florida — Orlando
Identifiers
NCT: NCT07748832 · STUDY00008626