Clinical trial NCT05959408: Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR)
Official title: Assessment of Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR) in Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Men Who Have Sex With Men
Keywords: Chlamydia trachomatis
Neisseria gonorrhoeae
Mycoplasma genitalium
viability PCR
Nucleic acid amplification tests
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial STIs in MSM.
Primary purpose: PREVENTION

Brief summary: It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM).

The main objective is to evaluate the proportion of pharyngeal, urogenital and anal specimens detected positive by nucleic acid amplification test (NAAT) for Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium that contain viable bacteria in MSM.

Detailed description: Screening for C. trachomatis and N. gonorrhoeae STIs at 3 anatomical sites, i.e. pharyngeal, urogenital and anal, is recommended every three to six months in MSM with high-risk sexual behaviors, using NAAT. A positive NAAT result defines the patient as infected, and the patient will receive antibiotic treatment. However, repeated use of antibiotics has led to the emergence of multi-drug resistant strains of M. genitalium, another STI agent, and N. gonorrhoeae, and to changes in the gut microbiota. One disadvantage of NAATs is that they amplify the nucleic acids of viable and dead bacteria. Thus, it is not possible to affirm that the patient has an "active" infection, defined by the presence of viable bacteria. Bacterial viability can be studied by real-time PCR (called V-PCR). This method combines the high sensitivity and specificity of PCR with the ability to exclude detection of nucleic acid remnants from non-viable bacteria. It does so by incorporating a sample pretreatment step with a membrane impermeable DNA intercalating dye prior to molecular analysis by blocking amplification of remnant DNA from non-viable bacteria. This allows the V-PCR analysis to detect DNA originating from intact (i.e. viable) bacteria. Using V-PCR, studies in women have shown that only half of the anorectal samples and one quarter of the pharyngeal samples positive for C. trachomatis contain viable bacteria.

The team proposes to investigate the presence of viable C. trachomatis, N. gonorrhoeae and M. genitalium bacteria by V-PCR in pharyngeal, urogenital and anal specimens from MSM detected as positive by NAAT for these bacteria.

The results of this work will allow us to assess whether all types of specimens tested in these patients contain viable bacteria, and if so, in what proportions.

Eligibility 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.

Primary outcomes:
measure: Proportion of pharyngeal, urogenital, and anal specimens that contain viable C. trachomatis, N. gonorrhoeae, and M. genitalium bacteria detected by V-PCR out of all specimens containing these same bacteria detected by NAAT in MSM
timeFrame: Day 1
Secondary outcomes:
measure: Ratio of the number of participants testing positive by NAAT and V-PCR, respectively, for C. trachomatis, N. gonorrhoeae, and M. genitalium at at least one site to the total number of participants.
timeFrame: Day 1
measure: Ratio of the number of pharyngeal, urogenital, and anal specimens testing positive for C. trachomatis, N. gonorrhoeae, or M. genitalium by NAAT and V-PCR, respectively, to the total number of pharyngeal, urogenital, and anal samples collected
timeFrame: Day 1
measure: Evaluate the rate of participants who received antibiotic treatment in the absence of viable bacteria in the sample out of all treated participants.
timeFrame: Day 1
measure: Ratio of bacterial load of viable bacteria to total bacterial load (viable and nonviable bacteria) in each specimen.
timeFrame: Day 1
measure: Ratio of the number of N. gonorrhoeae resistant to penicillin G, cefixime, ceftriaxone, azithromycin, tetracycline, spectinomycin and ciprofloxacin to the number of N. gonorrhoeae strains tested.
timeFrame: Day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Charles CAZANAVE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Olivia PEUCHANT, PharmD
role: STUDY_DIRECTOR
References: