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临床试验/NCT05789134
NCT05789134已完成不适用

Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 573 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
573
试验地点
1
主要终点
prevalence of MG infection

研究概览

简要总结

Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). While MG is treatable, antimicrobial resistance is a rising concern. This cross-sectional study aims to determine the prevalence of MG infection and the antimicrobial resistance pattern in HIV-infected male in Hong Kong.

A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. The main outcome measures include prevalence of MG and resistance mutations to macrolide/fluoroquinolone in HIV-infected male; prevalence of MG/STI co-infections, as defined by concurrent detection of MG and one or more other bacterial STI.

详细描述

A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. An online questionnaire would be self-administered. The participants would self-collect urine sample, rectal and pharyngeal swabs for MG, Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG) screening by nucleic acid amplification tests, and MG genotypic resistance mutations detection. Clinical data would be transcribed from medical records of recruited subjects.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • aged 18 or older, male, HIV-infected, and are attendees of the HIV specialist clinic, and can communicate in written and spoken English or Chinese

排除标准

  • not able to provide consent

结局指标

主要结局

prevalence of MG infection

时间窗: 1 year

detection of MG infections in self-collected samples divided by the total number of samples collected

prevalence of MG resistance mutations

时间窗: 1 year

* detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of MG positive samples * detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of samples collected

次要结局

  • prevalence of overall STI(1 year)
  • prevalence of CT infection(1 year)
  • prevalence of NG infection(1 year)
  • prevalence of syphilis(1 year)
  • prevalence of HCV infection(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ngai Sze WONG

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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