NCT02153008已完成不适用
Sofia Strep A FIA Field Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,708
- 试验地点
- 7
- 主要终点
- Detection of Group A Streptococcus
研究概览
简要总结
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.
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
- 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, 3 years of age or older
- •Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.
- •For example:
- •Acute onset of sore throat
- •Redness of the posterior pharyngeal wall
- •Difficulty/pain on swallowing
- •Fever, > 37.8º C (100ºF) at presentation or within past 24 hours
- •Pharyngeal exudate
- •Tender cervical lymphadenopathy
- •Absence of cough, runny nose or other upper respiratory symptoms.*
- •Other, symptoms specific to Strep A not listed above.
- •Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.
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
Detection of Group A Streptococcus
时间窗: Within 5 minutes
A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer
次要结局
未报告次要终点
研究者
研究点 (7)
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