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

复发性细菌性阴道病女性男性伴侣治疗的随机对照试验

• 批准号: 8330138
• 负责人: JANE R. SCHWEBKE
• 金额: $ 26.05万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-15 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8330138
• 关键词: Advocate; Archives; Bacteria; Bacterial Vaginosis; Behavioral; Budgets; Case Report Form; Clinical Treatment; Clinical Trials; Clinical Trials Data Monitoring Committees; Communities; Consent Forms; Couples; Data; Demographic Factors; Dose; Enrollment; Epidemiology; Etiology; Female; Funding; Future; Gardnerella vaginalis; Genital system; HIV; Infection; Investigation; Light; Manuals; Measures; Metronidazole; Microbial Biofilms; Molecular; Organism; Outcome; Pattern; Pelvic Inflammatory Disease; Pharmaceutical Preparations; Placebos; Play; Premature Birth; Preparation; Prevalence; Protocols documentation; Public Health; Randomized Controlled Trials; Recurrence; Regimen; Research Personnel; Risk; Risk Factors; Role; Sampling; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Site; Specimen; Syndrome; Techniques; Time; Training; Treatment Protocols; Vaginal Discharge; Vaginitis; Woman; adverse outcome; base; epidemiologic data; indexing; male; member; novel; operation; 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 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.

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病例只是由阴道革兰氏菌引起，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(对患有BV的女性只有50%有效)，并且没有衡量依从性，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样本，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。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)是全世界阴道炎的最常见原因，也与早产和感染/传播性传播性病/艾滋病毒的风险等不良后果有关。目前的治愈率很低，复发率很高。流行病学数据表明，这种感染可能是通过性传播的，但缺乏明确的数据。我们建议对患有复发性BV的女性的男性伴侣进行一项随机的安慰剂对照试验，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那里获得的样本来确定性伴侣中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。