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Pneumococcal Carriage Duration

4. august 2026 opdateret af: University of Central Florida

NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Florida
      • Orlando, Florida, Forenede Stater, 32827
        • Rekruttering
        • University of Central Florida
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study will enroll 60 healthy children under 4 years of age (30 aged 0-1 year, 30 aged 2-4 years) residing in Orlando, Florida. Children must be free of chronic or immuno-compromising conditions. Participants will be recruited from the community, pediatric clinics, and existing registries.

Beskrivelse

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:

    1. Provides written informed consent.
    2. Is able to read and speak English or Spanish.
    3. 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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Main Cohort
60 healthy children under 4 years of age (30 children aged 0-1 years, 30 children aged 2-4 years) residing in Orlando, Florida.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.
Tidsramme: One year
Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify its type (serotype) and compare it with other strains. Researchers will measure when a child first becomes colonized, when the bacteria are cleared (after two negative tests), how long colonization lasts, and how quickly new colonization occurs. Genetic analysis will determine whether the same strain persists or a new strain is acquired.
One year
Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years.
Tidsramme: One year
Respiratory samples will be tested to determine whether Streptococcus pneumoniae (pneumococcus) is present with other pneumococcal intra-subject lineages (ISL) using standard laboratory methods and genetic testing. If found, the bacteria will be genetically analyzed to identify the different types (serotype) and how many there are.
One year
Evaluate the feasibility and scalability of expanding the study to a larger sample size
Tidsramme: One year
One year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children
Tidsramme: One year
Respiratory samples will be tested for common viruses and bacteria using advanced laboratory methods. Researchers will also record whether participants have symptoms or are carrying these bacteria without feeling sick. They will track when a participant first acquires a new respiratory virus (one that was not detected at the previous visit) and calculate how often new infections occur over time, including comparisons by age group.
One year
Assessment of study methodologies
Tidsramme: One year
Researchers will compare different laboratory methods ( to see how well they detect Streptococcus pneumoniae and identify its type. They will also evaluate whether collecting samples every two weeks or once a month provides better information on bacterial carriage, new infections, and missing data. The study will compare different methods for analyzing the respiratory microbiome (the community of bacteria in the airways) and use computer models to determine whether microbiome patterns can predict pneumococcal carriage. Finally, researchers will compare the costs and practicality of different sampling schedules, collection methods, and laboratory tests to help guide future studies.
One year
To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.
Tidsramme: One year
The PI will identify the carriage of vaccine serotypes (VT) included in the most recent PCV administered to each participant. This analysis will compare VT versus NVT carriage prevalence, stratified by age group, vaccine, and time since vaccination.
One year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Central Florida

Samarbejdspartnere

Merck Sharp & Dohme LLC

Efterforskere

  • Ledende efterforsker: Dr. Taj Azarian, PhD, University of Central Florida

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

27. juli 2026

Først indsendt, der opfyldte QC-kriterier

4. august 2026

Først opslået (Faktiske)

6. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY00008626

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