RCT of Treatment of Male Partners of Women with Recurrent Bacterial Vaginosis

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病例可能仅仅是由于G。而另一些则是由生物体的多微生物群落引起的。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（对BV女性只有50%的有效性），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，我们将收集生殖器标本的夫妇，寻找一致的生物，特别是G。将这些样本进行收集和存档，以备将来用于确定与BV相关的不可培养微生物的患病率和一致性。这项R34申请是为了获得进行这种试验所需的所有准备工作的资金。 公共卫生相关性：细菌性阴道病（BV）是世界范围内阴道炎最常见的原因，也与不良后果有关，如早产和获得/传播STD/HIV的风险。目前的治愈率很低，复发率很高。流行病学数据表明，这种感染可能是性传播的，但缺乏确切的数据。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，以确定这种方法是否会降低女性的复发率。此外，我们将利用从这些性伴侣中获得的标本来确定性伴侣中BV相关细菌的一致性。这项R34申请是为了获得进行这种试验所需的所有准备工作的资金。

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 for 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. This R34 application is to obtain funding for all the preparations needed to conduct such a trial. PUBLIC HEALTH RELEVANCE: Bacterial vaginosis (BV) is the most common cause of vaginitis worldwide and is also associated with adverse consequences such as preterm birth and risk of acquiring/transmitting STD/HIV. Current cure rates are low and recurrence rates are high. Epidemiological data suggests that this infection may be sexually transmitted yet definitive data is lacking. We propose to conduct a randomized placebo controlled trial of treatment of the male partners of women with recurrent BV to determine if this approach results in decreased rates of recurrence in women. In addition we will utilize specimens obtained from these sexual couples to determine the concordance of BV-associated bacteria in sexual couples. This R34 application is to obtain funding for all the preparations needed to conduct such a trial.