NCT04753788已完成不适用
Clinical Evaluation of a Loop-mediated Isothermal Amplification Test for Treponema Pallidum Pertenue: A Diagnostic Tool to Support Yaws Eradication
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 3
- 主要终点
- Sensitivity of LAMP vs qpCR
研究概览
简要总结
This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lesion consistent with yaws
- •Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT
排除标准
- •Unable to give consent
结局指标
主要结局
Sensitivity of LAMP vs qpCR
时间窗: 15 Months
A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
Specificity of LAMP for Yaws
时间窗: 15 Months
Sample negative by qPCR for T.pallidum that is also negative by LAMP
次要结局
未报告次要终点
研究者
研究点 (3)
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