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临床试验/NCT02083276
NCT02083276终止2 期

Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Olaug Olsen

MD PhD

Oslo University Hospital

研究点 (1)

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