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

NCT05959408 | Unknown

• 1 other identifier: CHUBX 2022/52
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Men Who Have Sex With Men

Keywords

Chlamydia trachomatis; Neisseria gonorrhoeae; Mycoplasma genitalium; viability PCR; Nucleic acid amplification tests

Outcome Measures

Primary Outcomes (1)

• 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

  The quantitative real-time PCR, performed on the aliquots, will target the bacteria detected by NAAT on the native sample. The quantitative real-time PCR will be performed on the Light Cycler 480 (Roche Diagnostics); the calibration curve will permit to quantify the bacterial load (result expressed in equivalent genomes per mL).

  Day 1

Secondary Outcomes (5)

• 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.

  Day 1

• 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

  Day 1

• Evaluate the rate of participants who received antibiotic treatment in the absence of viable bacteria in the sample out of all treated participants.

  Day 1

• Ratio of bacterial load of viable bacteria to total bacterial load (viable and nonviable bacteria) in each specimen.

  Day 1

• 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.

  Day 1

Study Arms (1)

men who have sex with men

EXPERIMENTAL

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

Interventions

Collection of throat swab PROCEDURE

Introduction of a cotton swab for self-collection

men who have sex with men

Collection of anal swab PROCEDURE

Introduction of a cotton swab for self-collection

men who have sex with men

Collection of first void urine PROCEDURE

first void urine collected on urine pot

men who have sex with men

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Charles CAZANAVE, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Olivia PEUCHANT, PharmD

  University Hospital, Bordeaux

  STUDY DIRECTOR

Central Study Contacts

Olivia PEUCHANT, PharmD

CONTACT

+335 56 79 56 67; olivia.peuchant@chu-bordeaux.fr

Charles CAZANAVE, MD, PhD

CONTACT

+335 56 79 55 36; charles.cazanave@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial STIs in MSM.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: July 25, 2023
• Study Start: April 18, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)