Tinidazole for the Treatment of Bacterial Vaginosis

替硝唑治疗细菌性阴道病

• 批准号: 6893751
• 负责人: JANE R. SCHWEBKE
• 金额: $ 44.3万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6893751
• 关键词: African American; antiinfective agents; bacterial disease; clinical research; clinical trial phase III; communicable disease control; drug adverse effect; drug metabolism; drug screening /evaluation; female; genital secretion; health disparity; human subject; human therapy evaluation; metronidazole; microorganism disease chemotherapy; patient oriented research; pharmacokinetics; relapse /recurrence; sexually transmitted diseases; vaginitis; women' s health

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.

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，而且还与昂贵的并发症有关，例如早产，性病的获取和HIV获取/传播。已经主张对BV的控制减少这些并发症，但是由于目前可用的治疗方案不足，这是不可行的。 BV的特征是阴道菌群从乳杆菌的菌群转变为高浓度的厌氧和兼性厌氧生物的菌群。尽管BV的流行病学与性行为高度相关，但植物群转变的原因仍然未知。 BV用甲硝唑或克林霉素治疗的当前治疗方法是次优，治愈率约为70％，复发率高。替尼唑与甲硝唑相关的一种抗生素，在全球范围内广泛用于寄生虫感染，但在美国不可用的是，欧洲初步数据表明，由于其药代动力学概况，使用替替唑的治疗可能会导致BV的较高的替甲酸疗法。我们建议通过进行一项临床试验来研究这一假设，该试验比较了有症状女性的两种不同的替替唑剂与甲硝唑的贡献者。此外，我们将在治疗过程中测量药物的阴道和血清浓度，并与治疗率，短期复发BV以及感染的严重程度相关。