Choice of antibiotics for prophylaxis of bacterial STIs among individuals currently self-sourcing.
Manik Kohli, David Reid, Caisey V Pulford...
https://pubmed.ncbi.nlm.nih.gov/34873029Actively Recruiting
Age: 18Years +
MALE
Healthy Volunteers
ID06778083
STI Prophylaxis and Emergence of Antimicrobial Resistance
Led by University College, London · Updated on 2025-03-27
108
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the risk of antibiotic resistance and changes in the human microbiome among men who have sex with men (MSM) using antibiotics to prevent sexually transmitted infections (STI prophylaxis), specifically doxycycline post-exposure prophylaxis (doxyPEP). This observational study aims to understand how antibiotic use affects bacteria in the throat and gut, focusing on the development of resistance and microbiome changes. The study will involve 108 MSM participants, some who use doxyPEP and others who do not. Participants will visit the clinic every six months, where they will provide throat swabs and stool samples. These samples will be analyzed for bacterial DNA to identify species and detect antibiotic resistance genes. The study allows all enrolled participants to use doxycycline post-exposure prophylaxis during the study period. Participants will complete questionnaires at each visit to provide additional information. Researchers will monitor changes in antimicrobial resistance genes and microbiome composition over 12 months. The main outcome is the detection and characterization of resistance genes and microbiome changes during this time. The study includes safety monitoring and continues until April 2027, with participants involved in regular assessments every six months.
CONDITIONS
Brief Title
STI Prophylaxis and Emergence of Antimicrobial Resistance
Who Can Participate
Age: 18Years +
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged 65 18 years.
- Identifies as a man (cis or trans).
- Has sex with men.
- Able to provide informed consent.
You will not qualify if you...
- Use of an antibiotic other than doxycycline in the 3 months prior to enrolment.
- Currently being treated for an STI with doxycycline.
- Use of doxycycline within the prior 3 months for an indication other than STI treatment or STI prevention.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - 12 months
Participants who undergo routine care are observed to detect antimicrobial resistance genes and characterize the microbiome over time.
Visits at enrolment and periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Central and North West London NHS Foundation Trust
London, United Kingdom
Actively Recruiting
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Research Team
M
Manik Kohli, MBChB MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
BASHH updated position statement on doxycycline as prophylaxis for sexually transmitted infections.
Manik Kohli, Nicholas Medland, Helen Fifer...
https://pubmed.ncbi.nlm.nih.gov/35414633Impact of doxycycline post-exposure prophylaxis for sexually transmitted infections on the gut microbiome and antimicrobial resistome.
Victoria T Chu, Abigail Glascock, Deborah Donnell...
https://pubmed.ncbi.nlm.nih.gov/39363100Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial.
Jean-Michel Molina, Isabelle Charreau, Christian Chidiac...
https://pubmed.ncbi.nlm.nih.gov/29229440Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 × 2 factorial design.
Jean-Michel Molina, Beatrice Bercot, Lambert Assoumou...
https://pubmed.ncbi.nlm.nih.gov/38797183Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections.
Anne F Luetkemeyer, Deborah Donnell, Julia C Dombrowski...
https://pubmed.ncbi.nlm.nih.gov/37018493