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临床试验/NCT07671014
NCT07671014尚未招募不适用

A Preliminary Investigation to Determine the Utility of Using Metagenomic Analysis of Pharyngeal Samples Taken From Partners of Patients Diagnosed With Gonorrhoea to Identify Organisms, Antibiotics Resistance and Virulence Factors of Neisseria Species and the Impact of STI Prevention Strategies (4CMenB Vaccination and DoxyPEP)

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 100 人开始时间: 2026年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Neisseria species

研究概览

简要总结

The Neisseria gonorrhoea (NG) epidemic in England is at the highest level in one hundred years of public health records. The World Health Organisation has listed NG as one of the top five bacterial infections globally because of the ability of the bacteria to develop resistance to antibiotics. Neisseria meningitidis (NM) is a common pharyngeal commensal and it has been shown to be in one in five men who have sex with men (MSM) in London.

In the last year sexual health clinics have had a growing number of MSM presenting with urethritis / proctitis that were treated for NG on the day only to be found later to have been infected with NM from the culture. It appear that virulence factors have been passed from NG to NM enabling these bacteria to infect the urogenital and anal mucosa; consequently, NM in some cases is a new Sexually Transmitted Infection (STI). In 2025, two STI prevention interventions were rolled out in an attempt to address the gonorrhoea & syphilis epidemics and these were the 4CMenB vaccine and doxycycline post exposure prophylaxis (DoxyPEP).

This study will recruit sexual partners of patients who have been diagnosed with NG and the investigators will ask the participant for one additional pharyngeal sample for research that will not impact on their standard of care. The additional sample will be tested using metagenomics, that is where all non-human DNA is analysed, and the initial focus will be on NG or NM infection, co-infection, genes for virulence and antibiotic resistance from whole genome sequencing.

The metagenomic analysis is being undertaken for research purpose only; however, secondary outcomes will look for other STIs in the pharyngeal sample and sample turn around time to inform the management of patients. Any additional STI identified will have validated testing to confirm diagnosis.

详细描述

The main focus of this study is to develop a metagenomic assay for sexually transmitted infections (STIs) using samples taken from the pharynx of sexual partners of a patient who has been diagnosed with gonorrhoea.

Initial analysis will be on the Neisseria species (N. gonorrhoea [NG] & N.meningitidis [NM]) identified, co-infection, the virulence factors seen and mutations related to antibiotic resistance.

A full clinical history will be taken for each participant and the investigators will ask if they have had the 4CMenB vaccination (against NM with up to 30-40% protection against NG) or taken DoxyPEP (doxycycline 200mg taken after sex) because about 15% of NG is sensitive to tetracyclines.

The secondary research questions will focus on which other STIs are detectable using metagenomics in the pharynx. It is possible that there will be co-infections with Chlamydia trachomatis (serovars D-K and L1-3), Mycoplasma genitalium, Treponema pallidum, Human Papillomavirus and Herpes viruses.

The study will also explore the feasibility, turnaround times, and potential operational considerations associated with metagenomic sequencing within a sexual health research setting.

研究设计

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

入排标准

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

入选标准

  • Partner alerted of their risk about being a partner of someone diagnosed with Neisseria Gonorrhea using the digital partner notification software SXT and then booking an appointment for standard of care testing.

排除标准

  • Under 18 years, unable to speak English

研究组 & 干预措施

Sexual partner of someone diagnosed with Neisseria Gonorrhea infection

Partner alerted of their risk anonymous using SXT (http://sxt.health) and then these individuals booking an appointment to be seen for standard of care testing. If they are 18 years of age or older and can speak English then they will be offered the opportunity to join our observational study.

结局指标

主要结局

Neisseria species

时间窗: Within the week of sampling

Number of partners with Neisseria Gonorrhea or Neisseria Meningitidis infection identified in the pharynx, the presence of virulence factors and antibiotic resistance genes.

次要结局

  • Other sexually transmitted infections(Within one week of sample being taken)

研究者

申办方类型
Other
责任方
Sponsor

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