Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR) (VISTH)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Men Who Have Sex With Men

Treatments: Procedure: Collection of throat swab; Procedure: Collection of anal swab; Procedure: Collection of first void urine

Study type: Interventional

Funder types: Other

Identifiers

NCT05959408

CHUBX 2022/52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

men who have sex with men

Experimental group

Treatment:

Procedure: Collection of throat swab

Procedure: Collection of anal swab

Procedure: Collection of first void urine