Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 8
- 主要终点
- Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis
研究概览
简要总结
This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.
详细描述
This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men. The goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2) of multi-dose oral MTZ versus single-dose oral SEC. The investigators have several secondary analyses for Aim 1 including to examine if bacterial vaginosis (BV) interferes with T. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of T. vaginalis infection in both sexes.
If single-dose oral SEC is found to be superior to multi-dose oral MTZ, this could potentially result in an estimated 280,000 people in the U.S./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for HIV acquisition. It will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant T. vaginalis and BV.
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
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
- •Women and men aged 18 years or older of any race/ethnicity will be included in the study.
- •Participants must have either a positive T. vaginalis rapid antigen test (OSOM), or wet mount microscopy with motile trichomonads, or nucleic acid amplification test (NAAT) urinalysis or Pap smear positive for TV within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAAT testing at study enrollment,
- •Willing and able to provide and understand informed consent to comply with the study protocol,
- •Have a method of contact (either phone, email or social media),
- •Be willing to be randomized.
排除标准
- •Pregnant/lactating or seeking to be pregnant
- •Have been treated for with a 5-nitroimidazole (i.e. Metronidazole (MTZ), tinidazole (TDZ), or secnidazole [SEC]) in the last 28 days
- •Used intravaginal boric acid or any other intravaginal treatment for T. vaginalis in the last 14 days
- •Have a history of a type 1 hypersensitivity reaction to 5-nitroimidazole medications
- •Are taking phenytoin (Dilantin) and/or warfarin (Coumadin) due to drug-drug interactions with oral MTZ
- •Use of medications which may alter the metabolism of MTZ including Lithium and barbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital, primidone, secobarbital)
- •Have been previously enrolled in the study
研究组 & 干预措施
Single-Dose Secnidazole
Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men
干预措施: Secnidazole 2000 MG (Drug)
Oral Multi-Dose Metronidazole
Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
干预措施: Metronidazole 500 mg (Drug)
结局指标
主要结局
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis
时间窗: A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment
A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.
时间窗: A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment
A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit
次要结局
- To examine if BV co-infection interferes with T. vaginalis treatment(From enrollment to completion of one-month test of cure for those who test BV positive at baseline.)
- To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV.(From baseline visit to one-month test of cure visit)
- A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey.(From baseline visit to one-month test of cure visit)
- A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication.(at baseline, we document their prior test result (per medical records, survey or onsite testing).)
研究者
Patricia Kissinger
Principal Investigator
Tulane University