Tinidazole for the Treatment of Bacterial Vaginosis

描述（由申请人提供）：细菌性阴道病（BV）是全球最常见的阴道感染。它不仅引起令人痛苦的症状，而且还与早产、性病感染和艾滋病毒感染/传播等代价高昂的并发症有关。一直主张控制BV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。BV的特征在于阴道植物群从优势植物群转变为其中存在高浓度厌氧和兼性厌氧生物体的植物群。尽管BV的流行病学与性行为高度相关，但这种植物群变化的原因仍不清楚。目前用甲硝唑或克林霉素治疗BV是次优的，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，但在美国不可用。欧洲的初步数据表明，可能由于其药代动力学特征，用替硝唑治疗可能导致BV的治愈率显著提高。我们建议通过在有症状的妇女中进行一项比较替硝唑和甲硝唑两种不同给药方案的临床试验来研究这一假设。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短期复发和感染严重程度相关。

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.