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临床试验/NCT01832480
NCT01832480已完成3 期

Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Tulane University Health Sciences Center3 个研究点 分布在 1 个国家目标入组 623 人开始时间: 2014年10月6日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Single dose MTZ

干预措施: MTZ 2 g (Drug)

MTZ 500 mg twice daily x 7 days

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Kissinger

Professor

Tulane University Health Sciences Center

研究点 (3)

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