Randomized Controlled Trial of Treatment of Male Partners of Women 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，并与严重的产科、妇科和公共卫生并发症相关，包括性病/艾滋病感染和传播风险增加。人们一直提倡控制细菌性阴道炎以减少这些并发症的发生率，然而，细菌性阴道炎的病因尚不清楚，目前的治疗方案也不充分。流行病学证据有力地表明，细菌性阴道炎是通过性活动获得的，但由于病原体尚未明确确定，因此对性活动在细菌性阴道炎病因学中的确切作用的调查受到阻碍。很明显，阴道加德纳菌在这种综合征中起作用，因为它在所有患有细菌性阴道炎的妇女中都存在高浓度。较新的研究强调了未栽培生物在细菌性脑膜炎中的潜在作用。有新的数据表明，细菌性阴道炎是一个生物膜群落，有可能一些细菌性阴道炎病例仅仅是由阴道G菌引起的，而另一些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可能是主要病原体。就先前的临床试验而言，研究男性伴侣治疗的益处，20世纪80年代进行的研究要么未能显示男性伴侣治疗对女性BV复发的益处，要么显示出边际益处。然而，这些研究使用的是短期治疗（对女性细菌性阴阳炎患者只有50%的有效性），并且没有依从性措施，甚至没有与男性伴侣的直接互动。鉴于不断有数据表明性活动是BV的危险因素，我们建议对复发性BV的女性男性伴侣进行随机安慰剂对照试验，以观察男性治疗是否能减少女性指标病例的复发。此外，我们将收集夫妇的生殖器官标本，寻找生物的一致性，特别是阴道G菌，并将这些样本存档，以便将来用于确定与细菌性阴道炎相关的不可培养生物的患病率和一致性。

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.