Tinidazole for the Treatment of Bacterial Vaginosis

描述（申请人提供）：细菌性阴道病（BV）是世界上最常见的阴道感染。它不仅引起令人痛苦的症状，而且还与代价高昂的并发症有关，如早产、感染性病和感染/传播艾滋病毒。一直提倡控制细菌性阴道炎以减少这些并发症，但由于目前可用的治疗方案不足，这是不可行的。细菌性阴道炎的特点是阴道菌群从乳酸菌为主的菌群转变为高浓度的厌氧和兼性厌氧生物。尽管细菌性阴道炎的流行病学与性行为密切相关，但这种菌群变化的原因尚不清楚。目前使用甲硝唑或克林霉素治疗细菌性阴道炎并不理想，治愈率约为70%，复发率高。替硝唑是一种与甲硝唑相关的抗生素，在世界范围内广泛用于寄生虫感染，但在美国没有。欧洲的初步数据表明，可能是由于其药代动力学特征，用替硝唑治疗细菌性肠胃炎的治愈率明显更高。我们建议通过一项临床试验来研究这一假设，比较两种不同剂量的替硝唑和甲硝唑在有症状的妇女中的应用。此外，我们将测量治疗期间阴道和血清药物浓度，并与治愈率、BV短期复发率和感染严重程度相关联。

DESCRIPTION (provided by applicant): Bacterial vaginosis (BV) is the most common vaginal infection worldwide. It not only causes distressing symptoms but also is associated with costly complications such as preterm birth, STD acquisition and HIV acquisition/transmission. Control of BV has been advocated for decreasing these complications, however this is not feasible due to the fact that currently available treatment regimens are inadequate. BV is characterized by a shift in the vaginal flora from a lactobacillus predominant flora to one in which there are high concentrations of anaerobic and facultative anaerobic organisms. The cause of this shift in flora remains unknown although the epidemiology of BV is highly linked to sexual behavior. Current treatments for BV with metronidazole or clindamycin are suboptimal with cure rates at approximately 70% and high recurrence rates. Tinidazole, which is an antibiotic related to metronidazole, is widely used worldwide for parasitic infections but is not available in the U.S. There is preliminary European data that suggest, perhaps due to its pharmacokinetic profile, that treatment with tinidazole could result in significantly higher cure rates for BV. We propose to study this hypothesis by conducting a clinical trial comparing two different dosing regimens of tinidazole to metronidazole among symptomatic women. In addition, we will measure vaginal and serum concentrations of drug during treatment and correlate with cure rates, short-term recurrence of BV, and severity of infection.