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临床试验/ACTRN12618000219280
ACTRN12618000219280已完成2 期

Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: acceptability, tolerability and impact on the genital microbiota of couples - stage 2

Monash University0 个研究点目标入组 89 人开始时间: 2018年2月9日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
89

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Women will be eligible if they:
  • 1. are 18-55 years of age
  • 2. have symptomatic BV, microbiologically defined as a Nugent score of 4-10 and 3-4 Amsel criteria,
  • 3. are willing and able to comply with protocol requirements
  • 4. have a regular male partner who is willing to be enrolled in the trial
  • 5. must have been in a relationship with their regular male partner for at least two months at the time of enrolment
  • Men will be eligible if:
  • 1. their regular female partner meets the eligibility criteria
  • 2. they are willing and able to comply with protocol requirements, which includes enrolling within a week of their partner

排除标准

  • Women will be ineligible if they:
  • 1. are HIV positive
  • 2. are pregnant or breast feeding
  • 3. are diagnosed with current PID
  • 4. have an allergy to both first line antibiotics for BV, metronidazole and clindamycin
  • 5. test positive for C.trachomatis, N.gonorrhoeae or T.vaginalis at baseline
  • 6. have other current sexual partners
  • 7. are a current sex worker
  • Men will be ineligible if they:
  • 1. report a drug allergy to metronidazole or clindamycin,
  • 2. are HIV positive
  • 3. have other current sexual partners
  • 4. are a current sex worker

研究者

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