Metagenomic Analysis of the Pharynx in High Risk Partners

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Under 18 years, unable to speak English

Trial population

Most of the partners will be men who have sex with men as 80% of the diagnoses of gonorrhea are made in this group

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Sexual partner of someone diagnosed with Neisseria Gonorrhea infection

Trial outcomes

Primary outcomes

1

Neisseria species

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

Time frame
Within the week of sampling

Secondary outcomes

1

Other sexually transmitted infections

We will be able to identify if other sexually transmitted infections are present in the pharynx. Possible additional organisms include: Treponema pallidum, Chlamydia trachomatis, Mycoplasma genitalium, human herpes virus 1/2, Human Papillomavirus

Time frame
Within one week of sample being taken

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: