Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- clearance at week 3
研究概览
简要总结
It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium.
The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium
详细描述
Mycoplasma genitalium is a bacterium that colonizes female genital tract and can be responsible for sexually transmitted infection . M. genitalium can cause cervicitis and more rarely high genital infections.
In the vast majority of cases, presence of M. genitalium is not accompanied by any symptoms and women do not develop disease. Natural history of M. genitalium infection is not well documented. Some studies have shown a natural clearance of infection in women. The published work mainly concerns patients at very high risk of sexually transmitted disease, but we do not have French data.
We propose to study the natural clearance of M. genitalium infection in patients consulting at the Orthogeny Centre of the University Hospital of Bordeaux. Results of this work will allow us to have a better knowledge of the natural history of M. genitalium infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium.
- •Patient hospitalized for an abortion at the University Hospital of Bordeaux.
- •An affiliated patient or beneficiary of a social security system.
- •Signing free and informed consent.
排除标准
- •Patient with vaginal co-infection with C. trachomatis.
- •Patient with symptoms of high genital infection.
- •Taking fluoroquinolones, macrolides or tetracyclines within 21 days of inclusion.
- •Patient under legal protection.
结局指标
主要结局
clearance at week 3
时间窗: Week 3
The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.
次要结局
- Prevalence of N. gonorrhoeae infections(Week 3, Week 9)
- Prevalence of C. trachomatis infections(Week 3, Week 9)
- Prevalence of M. genitalium infections(Week 3, Week 9)
- clearance at week 9(Week 9)
- patient's sex life(Week 3, Week 9)