NCT00300534已完成不适用
Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
Centers for Disease Control and Prevention5 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2002年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Diagnosis of Treponema pallidum infection
研究概览
简要总结
The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients
排除标准
- •Less than age 18 years
研究组 & 干预措施
Abbott Laboratories Determine test for syphilis
No Intervention
Abbott Laboratories Determine rapid test for syphilis
干预措施: Abbott Laboratories Determine test for syphilis (Device)
Abbott Laboratories Determine test for syphilis
No Intervention
Abbott Laboratories Determine rapid test for syphilis
干预措施: Investigational syphilis immunochromatographic strip test (Device)
结局指标
主要结局
Diagnosis of Treponema pallidum infection
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (5)
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