NCT01086397已完成不适用
Distribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 782
- 试验地点
- 13
- 主要终点
- Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
研究概览
简要总结
The main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the US that is caused by certain types of the bacteria Streptococcus pneumoniae (also called pneumococcus).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years and older.
- •Presents to a study site with clinically suspected pneumonia.
- •Has a radiographic finding that is consistent with pneumonia.
- •Able and willing to provide urine.
排除标准
- •Transfer to a study hospital after already being hospitalized for 48 hours or more at any other inpatient facility (such as community hospital).
- •Hospital-acquired pneumonia (ie, pneumonia developing 48 hours after hospital admission).
- •Previous enrollment in this study within the past 30 days.
结局指标
主要结局
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae.
时间窗: 6-12 months
次要结局
- Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method.(6-12 months)
- Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site.(6-12 months)
- Serotype distribution of S. pneumoniae cases by site and across all sites.(6-12 months)
研究者
研究点 (13)
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