Pneumococcal Carriage Duration
2026年8月4日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dr. Amoy Fraser, PhD
- 电话号码：407-266-8742
- 邮箱：Amoy.Fraser@UCF.edu
研究联系人备份
- 姓名：Aniya Barclay, MS
- 电话号码：407-266-8742
- 邮箱：Aniya.Barclay@UCF.edu
学习地点
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Florida
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Orlando、Florida、美国、32827
- 招聘中
- University of Central Florida
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接触：
- Dr. Amoy Fraser, PhD
- 电话号码：407-266-8742
- 邮箱：Amoy.Fraser@UCF.edu
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接触：
- Aniya Barclay, MS
- 电话号码：407-266-8742
- 邮箱：Aniya.Barclay@UCF.edu
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.
大体时间：One year
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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.
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One year
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Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years.
大体时间：One year
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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.
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One year
|
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Evaluate the feasibility and scalability of expanding the study to a larger sample size
大体时间：One year
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One year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children
大体时间：One year
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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.
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One year
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Assessment of study methodologies
大体时间：One year
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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.
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One year
|
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To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.
大体时间：One year
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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.
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One year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Dr. Taj Azarian, PhD、University of Central Florida
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月21日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年7月27日
首先提交符合 QC 标准的
2026年8月4日
首次发布 (实际的)
2026年8月6日
研究记录更新
最后更新发布 (实际的)
2026年8月6日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.