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临床试验/NCT00324818
NCT00324818已完成4 期

Therapy and Prevention for Sexually Associated Bacterial Vaginosis

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2002年7月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
600
试验地点
2
主要终点
cure of bacterial vaginosis (BV)

研究概览

简要总结

We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV

详细描述

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated for decreasing the prevalence of these complications. The etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Further, half of all women who meet the clinical diagnostic criteria for BV are asymptomatic and treatment of these women remains controversial. More detailed characterization of the origins, natural history and response to therapy would supply data to guide control efforts. We will approach these problems through a multifaceted interdisciplinary evaluation of women with and without BV.

The specific aims {and hypotheses} of this project are:

  1. To conduct studies to determine optimal agents and duration of therapy for BV {Hypothesis: Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV; response to therapy differs between women with asymptomatic BV and symptomatic BV}
  2. To examine the role of condoms in the prevention of BV {Hypothesis: BV is a sexually transmitted infection, thus recurrence rates of BV will be lower among women with higher condom usage rates}
  3. To further explore the role of Mobiluncus spp., organisms strongly associated with the syndrome, by utilizing specimens derived from the above studies.

{Hypothesis: Mobiluncus is involved in the pathogenesis of BV at least in a subset of women, and the persistence of this organism is associated with lack of cure and recurrence of BV}

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Symptomatic bacterial vaginosis

排除标准

  • Pregnancy
  • Other genital infections

结局指标

主要结局

cure of bacterial vaginosis (BV)

percent of women without BV at follow up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Schwebke

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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