NIS103487 Duration of Streptococcus Pneumoniae Carriage in U.S. Children Under Five: A Pilot Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Oropharyngeal (OP) swab (Other)
结局指标
主要结局
Estimate the age- and serotype-specific carriage duration of Streptococcus pneumoniae in children aged 0-4 years.
时间窗: 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.
Estimate the age- and serotype-specific co-colonization rates of S. pneumoniae in children aged 0-4 years.
时间窗: 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.
Evaluate the feasibility and scalability of expanding the study to a larger sample size
时间窗: One year
次要结局
- Determine which viral and bacterial pathogens are present in respiratory specimens collected from enrolled children(One year)
- Assessment of study methodologies(One year)
- To identify carriage of pneumococcal serotypes among participants in the context of PCV vaccine history.(One year)