Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)
研究概览
简要总结
The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis infection has been macrolide antibiotics in the form of azithromycin, and alternatively tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg doxycycline a day. However, recent studies have reported increasing treatment failure that may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is evolving. Research regarding other bacterial species indicates a high frequency of mutation based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma genitalium infections. There has only been case reports of tetracycline resistance among human Chlamydia isolates, but a recent study suggest that there might be decreasing effectiveness also for doxycycline. Veterinaries has for several years observed increasing prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population there is promiscuous horizontal gene transfer.
If the current trend of declining cure rates continues, the investigators might face a situation where there are no documented and effective treatments for Chlamydia trachomatis infections. This underline an urgent need to expand the number of documented treatment options and mecillinam seems to be one of the options that warrant further investigation.
The objectives of this study is to prove the concept of treating genital Chlamydia trachomatis with mecillinam (Pivmecillinamhydrochlorid).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Proficient in oral and written Norwegian
- •Positive NAAT in first void urine for Chlamydia trachomatis
- •Negative NAAT in first void urine for Mycoplasma genitalium
- •Heterosexual male
- •Asymptomatic
排除标准
- •Known allergies for mecillinam, penicillin or cephalosporines
- •Metabolic anomalies of aciduric type
- •Apparent underweight
- •Use of mecillinam within the last two months
- •Under treatment with Valproat, other anti-infective drugs, immuno-modulating medication
- •In the opinion of investigator,obvious reasons why patient will fails to adhere to treatment and follow-up protocol
研究组 & 干预措施
Pivmecillinamhydrochlorid
Selexid 400 mg x 3 , 7 days
干预措施: Pivmecillinamhydrochlorid (Drug)
结局指标
主要结局
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)
时间窗: 3 weeks after end of treatment
次要结局
未报告次要终点
研究者
Anne Olaug Olsen
MD PhD
Oslo University Hospital
