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

描述(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有关，包括增加感染和传播STD/HIV的风险。控制BV是为了减少这些并发症的发生率，然而，BV的病因尚不清楚，目前的治疗方案也不够充分。流行病学证据有力地表明，BV是通过性行为获得的，但由于致病因素尚不清楚，对BV病因学中性行为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发挥了作用，因为它在所有患有BV的妇女中都存在高浓度。更新的研究强调了未培养生物在BV中的潜在作用。有新的数据表明，BV是一个生物被膜群落，有可能一些BV病例只是由阴道G菌引起，而另一些病例则是由更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。就以往研究男性伴侣的治疗益处的临床试验而言，S在1980年代进行的研究要么没有显示男性伴侣在女性BV复发中的治疗益处，要么显示了边际效益。然而，这些研究使用了短程疗法(只有50%有效)，并且没有衡量顺从程度，甚至没有与男性伴侣直接互动。鉴于持续的数据表明性行为是BV的危险因素，我们建议对复发BV的女性的男性伴侣进行随机安慰剂对照试验，看看男性治疗是否减少了女性指标病例的复发。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，特别是阴道革兰氏菌，并将这些样本存档，以供将来用于确定与BV相关的不可培养微生物的流行率和一致性。

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.