NCT02055742已完成不适用
Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 3
- 主要终点
- Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
研究概览
简要总结
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Any ethnicity or race
- •Subject >14 and <89 years of age
- •Subject who voluntarily gives written informed consent; not applicable for leftover specimens
- •Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
- •Leftover urine specimens
排除标准
- •Subjects < 14 or >90 years of age
- •Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
- •Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
- •Individuals who have been on antibiotic medications within 10 days.
- •Multiple sets of specimens from the same subject at different office visits
- •Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
- •Frozen archived specimens
结局指标
主要结局
Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
时间窗: Up to 60 days
Testing of each set of subject samples is completed within 60 days of sample collection
次要结局
未报告次要终点
研究者
研究点 (3)
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