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临床试验/NCT02694497
NCT02694497已完成不适用

Understanding Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women Receiving Routine Care; Implications for Control Strategies

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
560
试验地点
1
主要终点
Detection of Chlamydia after treatment.

研究概览

简要总结

Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular treatment to understand the transmission of anorectal CT infections.

详细描述

Rationale:

Current national and international strategies for the control of Chlamydia trachomatis (CT) critically fail to obtain a reduction in transmission. In women, anorectal infections are about as common as genital CT. Yet anorectal CT remain untested as sexually transmitted infection (STI) clinics, general practitioners, hospital and population testing initiatives largely focus on genital CT. Part of untested anorectal CT is incidentally treated with the treatments applied for genital CT, as in women anorectal CT is often concurrent with genital CT. Yet, it is unknown whether transmission of anorectal CT can still occur after currently recommended treatment. Anorectal and genital CT were observed quite often after regular treatment (up to 40% detection by nucleic acid amplification tests-NAAT). Proposed reasons for such detection include a new (re-)infection from a partner or self-infection from another anatomic, e.g. anorectal, site. Anorectal infections are a potential reservoir for ongoing transmission of genital and anorectal CT in the population, between partners and between anatomic sites of an individual. Yet, neither the transmission potential nor the transmission impact of anorectal infections has been reported. The scientific evidence for the optimal control strategy for anorectal CT and thereby CT in its totality, is lacking.

Objective:

To understand the transmission of anorectal CT infections in women, i.e. from their male sexual partner(s) and from and to the genital region of the same woman, in women who receive routine care, in order to inform guidelines to optimize CT control.

Study population:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Chlamydia trachomatis test positive (genital and or anorectal)

排除标准

  • (reported) co-infection with gonorrhoea
  • (reported) co-infection with HIV
  • (reported) co-infection with syphilis
  • (reported) pregnant
  • (reported) anti-Chlamydial antibiotic use (period screening-treatment)

结局指标

主要结局

Detection of Chlamydia after treatment.

时间窗: 0-12 weeks after regular treatment

Detection of anorectal and genital CT by NAAT

次要结局

  • Culture of Chlamydia after treatment(0-12 weeks after regular treatment)
  • CT concentration after treatment(0-12 weeks after regular treatment)
  • Viability PCR of Chlamydia after treatment(0-12 weeks after regular treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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