Pneumococcal CarriageNCT06373328
Post Pandemic Pneumococcal Carriage Among Children and Adults
An observational study of Pneumococcal Carriage, run by University of Central Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Carriage
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32827
Amoy Fraser, PhD, CCRP, PMP, 4072668742, amoy.fraser@ucf.edu
Britney-Ann Wray, BS, CCRP, CTBS, 4072668742, britney-ann.wray@ucf.edu
About this study
Official title: Post-Pandemic Genomic Epidemiology of Pneumococcal Carriage Among Children and Adults in the General US Population
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.
Read the detailed description
The SARS-CoV-2 pandemic profoundly impacted human health directly and indirectly. As such, elucidating pre- and post-pandemic trends in the epidemiology and population genomics of human respiratory pathogens including those such as the bacteria Streptococcus pneumoniae, a human commensal and the causative agent of invasive pneumococcal disease (IPD), merits study.
Nasopharyngeal samples will be processed at the PIs Laboratory to identify S. pneumoniae. If present, the isolate will undergo bacterial whole genome sequencings and population dynamic analysis. Carriage prevalence and serotype composition will be compared to extant studies and pneumococcal genomic data will be analyzed in the context of samples from the US and abroad.
- Conditions
- Pneumococcal Carriage
- Keywords
- Nasopharyngeal, Children, Pandemic, Genomic, Epidemiology, Pneumococcal Carriage, Streptococcus pneumoniae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR.
Measured: 22 months
Secondary outcomes (2)
Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.
Measured: 22 months
Putative transmission networks between children and adult populations from online questionnaires.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start12 Jun 2024
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal CarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme Corporation
- Responsible party
- Sponsor
- Investigators
- Taj Azarian, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373328
- Sponsor's protocol ID
- STUDY00006081
- Status last verified
- Dec 2024
- First submitted
- 11 Apr 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Pandemic Genomic Epidemiology of Pneumococcal Carriage Among Children and Adults in the General US Population
- ClinicalTrials.gov ID
- NCT06373328
- Acronym / sponsor ID
- STUDY00006081
- Conditions
- Pneumococcal Carriage
- Keywords
- Nasopharyngeal, Children, Pandemic, Genomic, Epidemiology, Pneumococcal Carriage, Streptococcus pneumoniae
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme Corporation
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The SARS-CoV-2 pandemic profoundly impacted human health directly and indirectly. As such, elucidating pre- and post-pandemic trends in the epidemiology and population genomics of human respiratory pathogens including those such as the bacteria Streptococcus pneumoniae, a human commensal and the causative agent of invasive pneumococcal disease (IPD), merits study.
Nasopharyngeal samples will be processed at the PIs Laboratory to identify S. pneumoniae. If present, the isolate will undergo bacterial whole genome sequencings and population dynamic analysis. Carriage prevalence and serotype composition will be compared to extant studies and pneumococcal genomic data will be analyzed in the context of samples from the US and abroad.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries.
Time frame: 22 months
Putative transmission networks between children and adult populations from online questionnaires.
Time frame: 22 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taj Azarian, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Carriage, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amoy Fraser, PhD, CCRP, PMP (4072668742, amoy.fraser@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.