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临床试验/EUCTR2019-003604-12-BE
EUCTR2019-003604-12-BE进行中(未招募)1 期

Evaluation of a chlorhexidine mouthwash for the eradication of asymptomatic pharyngeal Neisseria gonorrhoeae infection - MoNg study

Institute of Tropical Medicine0 个研究点目标入组 100 人开始时间: 2019年12月5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
100

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. Having had sex with another man within the previous 12 months
  • 5. Confirmed diagnosis of asymptomatic pharyngeal NG infection as defined by no symptoms of pharyngitis and no signs of disseminated gonococcal disease plus test positive for NG on NAAT or culture within the previous 14 days.
  • 6. Willing to abstain from any sexual intercourse until the result of the final test-of-cure is reported to be negative
  • 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 90
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • 1. Known contra-indication or allergy to chlorhexidine
  • 2. Proven gonococcal infection elsewhere, signs of disseminated gonococcal disease or proven or suspected coinfection with Chlamydia trachomatis (CT) or syphilis at the time of the screening visit.
  • 3. Currently using a mouthwash and unwilling to stop using it for the duration of the study or being included in another research project using mouthwashes
  • 4. Currently taking any antibiotics or having taken any antibiotics in the previous 14 days

研究者

发起方
Institute of Tropical Medicine

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