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临床试验/NCT05959408
NCT05959408招募中不适用

Assessment of Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR) in Men Who Have Sex With Men

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Proportion of pharyngeal, urogenital, and anal specimens that contain viable C. trachomatis, N. gonorrhoeae, and M. genitalium bacteria detected by V-PCR out of all specimens containing these same bacteria detected by NAAT in MSM

研究概览

简要总结

It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM).

The main objective is to evaluate the proportion of pharyngeal, urogenital and anal specimens detected positive by nucleic acid amplification test (NAAT) for Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium that contain viable bacteria in MSM.

详细描述

Screening for C. trachomatis and N. gonorrhoeae STIs at 3 anatomical sites, i.e. pharyngeal, urogenital and anal, is recommended every three to six months in MSM with high-risk sexual behaviors, using NAAT. A positive NAAT result defines the patient as infected, and the patient will receive antibiotic treatment. However, repeated use of antibiotics has led to the emergence of multi-drug resistant strains of M. genitalium, another STI agent, and N. gonorrhoeae, and to changes in the gut microbiota. One disadvantage of NAATs is that they amplify the nucleic acids of viable and dead bacteria. Thus, it is not possible to affirm that the patient has an "active" infection, defined by the presence of viable bacteria. Bacterial viability can be studied by real-time PCR (called V-PCR). This method combines the high sensitivity and specificity of PCR with the ability to exclude detection of nucleic acid remnants from non-viable bacteria. It does so by incorporating a sample pretreatment step with a membrane impermeable DNA intercalating dye prior to molecular analysis by blocking amplification of remnant DNA from non-viable bacteria. This allows the V-PCR analysis to detect DNA originating from intact (i.e. viable) bacteria. Using V-PCR, studies in women have shown that only half of the anorectal samples and one quarter of the pharyngeal samples positive for C. trachomatis contain viable bacteria.

The team proposes to investigate the presence of viable C. trachomatis, N. gonorrhoeae and M. genitalium bacteria by V-PCR in pharyngeal, urogenital and anal specimens from MSM detected as positive by NAAT for these bacteria.

The results of this work will allow us to assess whether all types of specimens tested in these patients contain viable bacteria, and if so, in what proportions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Males > 18 years
  • Men who have sex with men
  • Participant consulting at the Bordeaux University Hospital
  • Oral consent to participate in the study
  • Member or beneficiary of a social security system

排除标准

  • Participant < 18 years
  • Participant subject to a legal protection measure (protection of the court, guardianship or curator).
  • Participant deprived of liberty by judicial or administrative decision.

结局指标

主要结局

Proportion of pharyngeal, urogenital, and anal specimens that contain viable C. trachomatis, N. gonorrhoeae, and M. genitalium bacteria detected by V-PCR out of all specimens containing these same bacteria detected by NAAT in MSM

时间窗: Day 1

The quantitative real-time PCR, performed on the aliquots, will target the bacteria detected by NAAT on the native sample. The quantitative real-time PCR will be performed on the Light Cycler 480 (Roche Diagnostics); the calibration curve will permit to quantify the bacterial load (result expressed in equivalent genomes per mL).

次要结局

  • Evaluate the rate of participants who received antibiotic treatment in the absence of viable bacteria in the sample out of all treated participants.(Day 1)
  • Ratio of bacterial load of viable bacteria to total bacterial load (viable and nonviable bacteria) in each specimen.(Day 1)
  • Ratio of the number of pharyngeal, urogenital, and anal specimens testing positive for C. trachomatis, N. gonorrhoeae, or M. genitalium by NAAT and V-PCR, respectively, to the total number of pharyngeal, urogenital, and anal samples collected(Day 1)
  • Ratio of the number of N. gonorrhoeae resistant to penicillin G, cefixime, ceftriaxone, azithromycin, tetracycline, spectinomycin and ciprofloxacin to the number of N. gonorrhoeae strains tested.(Day 1)
  • Ratio of the number of participants testing positive by NAAT and V-PCR, respectively, for C. trachomatis, N. gonorrhoeae, and M. genitalium at at least one site to the total number of participants.(Day 1)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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