NCT01441479已完成不适用
Strep A Fluorescent Immunoassay and Analyzer Field Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,282
- 试验地点
- 7
- 主要终点
- Streptococcus Group B identification
研究概览
简要总结
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects three (3) years of age or older
- •Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis
- •Extreme sore throat
- •Redness of the posterior pharyngeal wall
- •Difficulty Swallowing
- •Fever, >38.7C (100F) at presentation or within past 24 hours
- •Pharyngeal exudate
- •Tender cervical lymphadenopathy
- •Absence of cough or other upper respiratory symptoms
排除标准
- •Subjects currently under treatment with antibiotics are not to be included in this study.
- •At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
结局指标
主要结局
Streptococcus Group B identification
时间窗: Immediate
The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.
次要结局
未报告次要终点
研究者
研究点 (7)
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