Evaluating the viability of bacterial STIs in men who have sex with men
Assessment of Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR) in Men Who Have Sex With Men
This study is testing a new method to see if bacterial STIs are still active in men who have sex with men by collecting samples from different areas of the body.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05959408 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the viability of bacterial sexually transmitted infections (STIs) such as Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium in men who have sex with men (MSM). It involves collecting samples from three anatomical sites: pharyngeal, urogenital, and anal, and analyzing them using a novel viability PCR (V-PCR) method. This method distinguishes between viable and non-viable bacteria, addressing the limitations of traditional nucleic acid amplification tests (NAATs) that cannot confirm active infections. The study is conducted at the Bordeaux University Hospital and targets high-risk MSM populations for more accurate STI management.
Who should consider this trial
Good fit: Ideal candidates for this study are males over 18 years who identify as men who have sex with men and are consulting at the Bordeaux University Hospital.
Not a fit: Patients under 18 years or those under legal protection measures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for STIs by accurately identifying active infections.
How similar studies have performed: Previous studies using viability PCR in women have shown promising results, indicating that this approach may also be effective in men.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Bordeaux
- Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Charles CAZANAVE, MD, PhD — University Hospital, Bordeaux
- Study coordinator: Olivia PEUCHANT, PharmD
- Email: olivia.peuchant@chu-bordeaux.fr
- Phone: +335 56 79 56 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.