Evaluating the inflammatory, microbiome profile and co-infections in women diagnosed with treatment failure, relapse or recurrent Bacterial vaginosis -A Prospective analytic study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,067
- 试验地点
- 2
- 主要终点
- 1.Identify the species common in treatment failure ,relapse and recurrent Bacterial vaginosis
研究概览
简要总结
Summary:
Background-Bacterial vaginosis is a highly prevalent reproductive tract infection with reported prevalence from India range from 21% to 44.8% in different settings. Despite giving standard antimicrobials like metronidazole or secnidazole the short term cure is 30-40% in international studies recurrence rate is high greater than 50%.
Novelty- This prospective study will help us to understand the burden of women suffering from recurrent/relapse and treatment failure BV. It will correlate the changes in vaginal microbiota, Nugent score, Amsel criteria and inflammatory markers and thereby give composite information on women suffering from recurrent/relapse/treatment failure and compare it those in remission.
Objectives- To assess the profile and possible determinants of recurring or relapse or treatment failure BV
**Methods-**Women reporting with complaints of lower genital tract infection will be screened and those with BV will be identified. This group will be given treatment as per syndromic approach and will be followed up to identify relapse, reoccurrence, treatment failure and remission cases. Vaginal swab, cervicovaginal lavage and gram staining samples will be collected and analyzed using Nugent score, Amsel criteria,16S rRNA gene sequencing(three times) and cytokine analysis(three times)
Expected outcome-This study will identify the specific species common in treatment failure ,relapse and recurrent Bacterial vaginosis. This study will be give insights into longitudinal changes in the host immune response. This study will be further used to design a randomized control trial, based on the evolving treatment options of recurrent or persistent BV
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age 18-55 2.Sexually active 3.Women willing to come for follow up 4.Women having single sexual partners.
排除标准
- •1.Asymptomatic women first time 2.Women not taken any antibiotic or antifungal for last 4 weeks 3.Have hypersensitivity or a contraindication to all first line drugs used to treat BV.
结局指标
主要结局
1.Identify the species common in treatment failure ,relapse and recurrent Bacterial vaginosis
时间窗: 7 days,30-40,6 months,9 months,one year
2.It will help to know the prevalence of recurrent,relapse and treatment faliure BV
时间窗: 7 days,30-40,6 months,9 months,one year
次要结局
- 1.Common Sexually transmitted infections among women taking treatment for STI(one year)