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）是美国最常见的阴道分泌物原因，与严重的产科、妇科和公共卫生并发症相关，包括增加获得和传播STD/HIV的风险。控制BV已被提倡降低这些并发症的患病率，然而，BV的病因仍然不明，目前的治疗方案是不够的。流行病学证据有力地表明，BV是通过性活动获得的，然而，由于病原体尚未明确，因此对性活动在BV病因学中的确切作用的调查受到阻碍。很明显，Gardnerella vagulosa在这种综合征中起作用，因为它在所有BV女性中以高浓度存在。新的研究强调了未培养的微生物在BV中的潜在作用。有新的数据表明，BV是一个生物膜群落，有些BV病例可能只是由于G迷走神经，而其他病例则是由更多的微生物群落引起的。或者，其中一种未培养的生物体可能是主要病原体。在检查男性伴侣治疗益处的先前临床试验方面，20世纪80年代进行的研究未能显示男性伴侣治疗女性BV复发的益处或显示边际益处。然而，这些研究使用了短期治疗（只有50%的有效性或BV女性），并且没有测量依从性，甚至没有与男性伴侣的直接互动。鉴于持续的数据表明性活动是BV的危险因素，我们建议对复发性BV女性的男性伴侣进行随机安慰剂对照试验，以观察男性治疗是否会降低女性指标病例的复发率。此外，我们将收集夫妇的生殖器标本，以寻找生物体的一致性，特别是G vagulovirus，并将这些样本存档，以供将来用于确定与BV相关的不可培养生物体的患病率和一致性。