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临床试验/EUCTR2021-003616-10-BE
EUCTR2021-003616-10-BE进行中(未招募)1 期

An open label randomized controlled trial comparing the effect of ceftriaxone plus azithromycin versus ceftriaxone for the treatment of Neisseria gonorrhoeae on the resistome - ResistAZM Trial

Institute of Tropical Medicine0 个研究点目标入组 42 人开始时间: 2021年10月15日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
42

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • 1.Able and willing to provide written informed consent
  • 2.Male sex at birth
  • 3.At least 18 years old
  • 4.Confirmed diagnosis of urethritis, proctitis or pharyngitis Ng – symptomatic or asymptomatic (Diagnosis of Ng will be by a positive NAAT performed according to the ITMs current laboratory protocols or for patients with urethritis a positive gram/methylene blue stain)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 38
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 4

排除标准

  • 1.Use of any macrolide antibiotics (azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin) in previous 6 months
  • 2.Known contra-indications or allergy to ceftriaxone, azithromycin or lidocaine
  • 3.Presence of any other condition, including other STIs that will (likely) require the administration of another antibiotic at the time of enrollment, as assessed by the treating physician

研究者

发起方
Institute of Tropical Medicine

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