Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
赞助:
Ellume Pty Ltd
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | March 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture[ Time Frame: 1 Week ] The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture[ Time Frame: 1 Week ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis | ||
| 正式标题 ICMJE | A Prospective Multi-Centre Study of the Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis | ||
| 简要概况 | Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Diagnostic |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
500 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 2019 | ||
| 预计主要完成日期 | March 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Male and female participants aged 3 years of age or older - Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including: - Acute onset of sore throat; - Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and; - At least one of the following: - Red and swollen/inflamed tonsils (or fossae); - Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy - ≤ 14 days from onset of signs and symptoms of pharyngitis - Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent - Participants ≥18 years of age capable and willing to give informed consent Exclusion Criteria: - Participants < 3 years of age - Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis - Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent - Participants 18 years of age or older unable to understand English and consent to participation - Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child - Prior enrollment in this clinical validation study | ||
| 性别 |
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| 年龄 | 最小年龄：3 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Ellume Pty Ltd | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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