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
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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