NCT01728103终止不适用
Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,336
- 试验地点
- 14
- 主要终点
- Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease
研究概览
简要总结
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal intercourse within the past 12 months)
- •The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board [IRB]-approved waiver for parental consent for minors)
- •In addition, the subject must meet at least one of the following criteria:
- •The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- •Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
- •Subject is asymptomatic and undergoing screening evaluation for possible STIs
- •Subject is asymptomatic and undergoing a routine examination with a pelvic examination
排除标准
- •The subject took antibiotic medications within the last 21 days
- •Subject already participated in this study
- •Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
- •Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
结局指标
主要结局
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease
时间窗: approximately one year
次要结局
未报告次要终点
研究者
研究点 (14)
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