Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 3
- 主要终点
- Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)
研究概览
简要总结
The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
详细描述
This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open label study
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •>= 18 years old
排除标准
- •HIV-infected
- •unable to provide informed consent
- •breast feeding
- •treated by their provider for Bacterial vaginosis (BV) at visit
研究组 & 干预措施
MTZ 2 g
Single dose MTZ
干预措施: MTZ 2 g (Drug)
MTZ 500 mg twice daily x 7 days
Multi dose MTZ
干预措施: MTZ 500 mg twice daily x 7 days (Drug)
结局指标
主要结局
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)
时间窗: 4 weeks post treatment completion
Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.
次要结局
未报告次要终点
研究者
Patricia Kissinger
Professor
Tulane University Health Sciences Center
