Metagenomic Analysis of the Pharynx in High Risk Partners

NCT07671014 | Not Yet Recruiting

• 1 other identifier: IRAS 368188
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gonorrhea; Neisseria Gonorrhea; Neisseria Meningitidis; Metagenomic Next Generation Sequencing

Keywords

Gonorrhea; Metagenomic testing; Neisseria Gonorrhoea; Neisseria Meningitis

Outcome Measures

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.

  Within the week of sampling

Secondary Outcomes (1)

• Other sexually transmitted infections

  Within one week of sample being taken

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years, unable to speak English

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Related Publications (1)

• Alcolea-Medina A, Snell LB, Humayun G, Al-Yaakoubi N, Ward D, Alder C, Patel V, Vivian F, Meadows CIS, Wyncoll D, Paul R, Barratt N, Batra R, Edgeworth J, Nebbia G, Whitehorn J. Rapid pan-microbial metagenomics for pathogen detection and personalised therapy in the intensive care unit: a single-centre prospective observational study. Lancet Microbe. 2025 Oct;6(10):101174. doi: 10.1016/j.lanmic.2025.101174. Epub 2025 Oct 1.

  PMID: 41045941 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Pharyngeal sample from patient identified as a partner of someone who has been diagnosed with a Neisseria Gonorrhea infection.

MeSH Terms

Conditions

Gonorrhea; Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Central Study Contacts

Anatole S Menon-Johansson, BSc, PhD, MB, BChir, MPH, MBA

CONTACT

+447900212512; a.menon-johansson@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: By the end of February 2027
• Access Criteria: This information will be provided in the publications