Randomized Controlled Trial of Treatment of Male Partners of Women with BV

患有 BV 的女性男性伴侣治疗的随机对照试验

• 批准号: 8892060
• 负责人: JANE R. SCHWEBKE
• 金额: $ 58.48万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-17 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8892060
• 关键词: Advocate; Archives; Bacteria; Bacterial Vaginosis; Behavioral; Clinical Treatment; Clinical Trials; Communities; Couples; Data; Demographic Factors; Dose; Epidemiology; Etiology; Female; Future; Gardnerella vaginalis; Genital system; HIV; Health; Infection; Investigation; Light; Measures; Metronidazole; Microbial Biofilms; Molecular; Organism; Outcome; Pattern; Pelvic Inflammatory Disease; Pharmaceutical Preparations; Placebos; Play; Premature Birth; Prevalence; Public Health; Randomized Controlled Trials; Recurrence; Regimen; Risk; Risk Factors; Role; Sampling; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Specimen; Syndrome; Techniques; Time; Treatment Protocols; Vaginal Discharge; Vaginitis; Woman; adverse outcome; base; epidemiologic data; indexing; male; novel; pathogen; randomized placebo controlled trial; sex; transmission process

DESCRIPTION (provided by applicant): Bacterial vaginosis (BV) is the most prevalent cause of vaginal discharge in the U.S. and is associated with serious obstetrical, gynecological, and public health complications including increased risk for acquisition and transmission of STD/HIV. Control of BV has been advocated for decreasing the prevalence of these complications, however, the etiology of BV remains unknown and current treatment regimens are inadequate. Epidemiologic evidence strongly suggests that BV is acquired through sexual activity, yet since the causative agent is not clearly established, investigations into the exact role of sexual activiy in the etiology of BV are hampered. It is clear that Gardnerella vaginalis plays a role in this syndrome since it is present in high concentrations in all women with BV. Newer investigations have highlighted the potential role of uncultivated organisms in BV. There is new data to suggest that BV is a biofilm community and it is possible that some cases of BV are simply due to G vaginalis while others are caused by a more polymicrobic community of organisms. Alternatively, one of the uncultivated organisms could be a primary pathogen. In terms of previous clinical trials examining the benefit of treatment of the male partner, studies conducted in the 1980's either failed to show a benefit of treatment of the male partner in recurrences of BV in the female or showed marginal benefit. However, these studies used short-course therapy (which is only 50% effective or women with BV) and had no measures of compliance or even direct interaction with the male partner. In light of continuing data implicating sexual activity a a risk factor for BV, we propose to conduct a randomized placebo controlled trial of treatment of the male partners of women with recurrent BV to see if treatment of the male decreases recurrence in the female index case. In addition we will collect genital specimens from the couples to look for concordance of organisms especially G vaginalis and archive these samples for future use in determining the prevalence and concordance of uncultivatable organisms associated with BV.

描述（由申请人提供）：细菌性阴道病（BV）是美国阴道排出的最普遍原因，与严重的产科，妇科和公共卫生并发症有关，包括增加收购和传播性病/HIV的风险。已经主张对BV的控制降低这些并发症的患病率，但是，BV的病因仍然未知，并且当前的治疗方案不足。流行病学证据强烈表明，通过性活动获得了BV，但是由于没有明确确定病因，因此对性活动在BV病因中的确切作用进行了调查。很明显，加德纳（Gardnerella daginalis）在该综合征中起着作用，因为它在所有BV的女性中都具有高浓度。较新的研究强调了未经培养的生物在BV中的潜在作用。有新的数据表明，BV是一个生物膜社区，某些BV的情况可能仅仅是由于G阴道造成的，而其他BV则是由更多年生物体引起的。另外，未经培养的生物之一可能是主要病原体。在先前检查男性伴侣治疗的益处的临床试验方面，在1980年代进行的研究要么未能显示出男性伴侣在BV中的治疗中的益处，要么表现出边缘益处。但是，这些研究使用了短道疗法（只有50％有效或具有BV的女性），并且没有遵守措施，甚至没有与男性伴侣进行直接互动。鉴于持续的数据暗示性活动是BV的危险因素，我们建议对重复BV的男性伴侣进行随机安慰剂对照试验，以查看男性治疗是否会减少女性指数案例的复发性。此外，我们将从夫妻中收集生殖器标本，以寻找生物的一致性，特别是阴道和这些样品，以确定与BV相关的不可养生生物的普遍性和一致性。