A randomized crossover study to evaluate the efficacy of antibacterial mouthwash in preventing pharyngeal gonorrhea among a high risk population

淋病是美国最常报告的传染病之一， 近几年大幅。包括咽部淋病在内的淋病患病率特别高 报告男性性伴侣的男性中。2010年至2017年，淋病的估计发病率 在报告男性性伴侣的男性中增加了283%，明显高于80%的男性。 在美国其他男性中看到的增长。口服（即，咽部）感染淋病， 被认为是这些增长率的主要驱动力。减少咽部淋病的干预措施 对淋病的总体发病率可能产生重大的人群影响。初步数据显示， 市售漱口水（抗菌Listerine®漱口水）的保护作用， 咽部淋病鉴于漱口水是广泛可用的，易于使用，并且相对便宜， 有可能作为一个重要的淋病预防战略之间的高度影响的人口。 然而，还需要进一步的研究来了解漱口水对整体的抑制作用， 口腔中的细菌负荷转化为降低获得咽部淋病的风险。因此 本研究的目的是：（1）检查日常使用漱口水预防 咽部淋病;（2）测量每日使用抗菌漱口水的初步疗效， 与安慰剂漱口水相比， 冒险的男人为了实现这一点，我们建议进行一项研究，将利用现有的队列研究 旨在评估药物使用和艾滋病毒对少数群体男子的流行病学和免疫影响 与男性发生性关系的人（mStudy）。我们将采用随机交叉研究设计， 拟定的研究将是mSTUDY中入组的既往诊断为咽部疾病的患者。 淋病一半的参与者将被随机分配，首先接受抗菌漱口水或 安慰剂漱口水，所有参与者将在干预后12周进行咽部淋病检测。 在第12周，参与者将“交叉”到他们所在的替代干预组。 基线时随机分组。这样，那些被分配到活性漱口水组的人将转而使用安慰剂 漱口水，反之亦然，然后所有参与者将被跟踪另外12周，并将被测试 在交叉干预12周后再次出现咽部淋病（即，研究后24周 登记）。这项研究的结果将有助于我们了解其潜在的可接受性， 为抗菌漱口水预防咽部淋病的有效性提供初步证据。

Gonorrhea is one of the most commonly reported infectious diseases in the United States and has increased substantially in recent years. The prevalence of gonorrhea, including pharyngeal gonorrhea is particularly high among men who report male sex partners. Between 2010 and 2017 the estimated rates of gonorrhea increased by 283% among men who report male sex partners, which was significantly higher than the 80% increase seen among other men in the United States. Oral (i.e., pharyngeal) infections with gonorrhea are thought to be a major driver of these increasing rates. Interventions to reduce pharyngeal gonorrhea have the potential for significant population impact on the overall incidence of gonorrhea. Preliminary data suggest a protective effect of commercially available mouthwash (antibacterial Listerine® mouthwash) against pharyngeal gonorrhea. Given that mouthwash is widely available, easy to use, and relatively inexpensive it has the potential to serve as an important gonorrhea prevention strategy among a highly impacted population. However, further studies are needed to understand whether the inhibitory effects of mouthwash on overall bacterial load in the oral cavity translate to reduced risk of acquisition of pharyngeal gonorrhea. Therefore, the objectives of this study are to: (1) examine the acceptability of daily mouthwash use for the prevention of pharyngeal gonorrhea; and (2) measure the preliminary efficacy of daily use of antibacterial mouthwash as compared to a placebo mouthwash in reducing the incidence of pharyngeal gonorrhea among a cohort of high risk men. To accomplish this we propose to conduct a study that will leverage an existing cohort study designed to assess the epidemiological and immunological impact of substance use and HIV on minority men who have sex with men (mSTUDY). We will use a randomized crossover study design and participants in the proposed study will be those enrolled in the mSTUDY who have been previously diagnosed with pharyngeal gonorrhea. Half the participants will be randomized to first receive either the antibacterial mouthwash or the placebo mouthwash and all participants will be tested for pharyngeal gonorrhea at 12-weeks post intervention. At the 12-week mark participants will `crossover' to the alternative intervention group from which they were randomized at baseline. In this way, those assigned to the active mouthwash group will switch to the placebo mouthwash and vice versa and all participants will then be followed for another 12-weeks and will be tested for pharyngeal gonorrhea again after 12-weeks of cross-over intervention (i.e., 24 weeks following study enrollment). Findings from this study will contribute to our understanding of its potential acceptability and provide preliminary evidence of the efficacy of antibacterial mouthwash in preventing pharyngeal gonorrhea.