Assessing the Impact of PCV13 on Pneumococcal Nasopharyngeal Colonization in Children 8 Weeks to ≤60 Months of Age Hospitalized for Pneumonia in the Philippines
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- Antimicrobial resistance rate of S. pneumoniae
研究概览
简要总结
Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).
详细描述
This study will be the first of two phases (A and B). Phase A will compare a PCV13-vaccinated setting (SPMC) with an unvaccinated setting (PCMC)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Weeks 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child 8 weeks to ≤60 months of age
- •Resident of the National Capital Region (NCR) or Region X-XIII
- •Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
- •Written informed consent obtained from a parent or legal guardian
- •At SPMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking
- •For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at <12 months based on history-taking
排除标准
- •Children with a known primary or secondary immunodeficiency
- •Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32
- •For Phase A at PCMC site, child with any PCV in the past based on history-taking
结局指标
主要结局
Antimicrobial resistance rate of S. pneumoniae
时间窗: Upon Admission
Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC)
S. pneumoniae serotypes Upon Admission
时间窗: Upon Admission
S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)
S. pneumoniae serotypes
时间窗: Upon Admission
S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)
次要结局
未报告次要终点
研究者
Marilla Lucero
Principal Investigator
Asian Foundation for Tropical Medicine Inc.