Men Who Have Sex With MenVISTHNCT05959408
Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR)
A study testing Collection of throat swab, Collection of anal swab and Collection of first void urine in people with Men Who Have Sex With Men, run by University Hospital, Bordeaux at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Men Who Have Sex With Men
- What is being tested?
- Collection of throat swab, Collection of anal swab and Collection of first void urine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin
Bordeaux
Charles CAZANAVE, MD, PhD, +335 56 79 55 23 ext. +33, charles.cazanave@chu-bordeaux.fr
Pauline PERREAU, PhD, +335 57 82 11 03 ext. +33, pauline.perreau@chu-bordeaux.fr
About this study
Official title: Assessment of Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR) in Men Who Have Sex With Men
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.
Read the 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.
- Conditions
- Men Who Have Sex With Men
- Being tested
- Collection of throat swab, Collection of anal swab, Collection of first void urine
- Keywords
- Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, viability PCR, Nucleic acid amplification tests
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of throat swabProcedure or surgery
Introduction of a cotton swab for self-collection
Collection of anal swabProcedure or surgery
Introduction of a cotton swab for self-collection
Collection of first void urineProcedure or surgery
first void urine collected on urine pot
| Study group | Role | What they receive |
|---|---|---|
| men who have sex with men | Experimental | Not described Receives: Procedure: Collection of throat swab; Procedure: Collection of anal swab; Procedure: Collection of first void urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Prevalence of C. trachomatis, N. gonorrhoeae, and M. genitalium infections detected by NAAT versus V-PCR calculated
Measured: 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
Prevalence of C. trachomatis, N. gonorrhoeae, and M. genitalium infections detected by NAAT versus V-PCR calculated
Measured: 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.
Number of participants who will have received antibiotic treatment in the absence of viable bacteria divided by the total number of participants with a positive NAAT result.
Measured: Day 1
Ratio of bacterial load of viable bacteria to total bacterial load (viable and nonviable bacteria) in each specimen.
Ratio of bacterial load of viable bacteria determined by quantitative real-time PCR (gEq/µL) to total bacterial load (viable and nonviable bacteria) determined by quantitative real-time PCR (gEq/µL) in each specimen.
Measured: 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.
Prevalence of N. gonorrhoeae resistance to penicillin G, cefixime, ceftriaxone, azithromycin, tetracycline, spectinomycin, and ciprofloxacin assessed by the 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start18 Apr 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men Who Have Sex With MenStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial STIs in MSM.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles CAZANAVE, MD, PhD, Principal investigator, University Hospital, BordeauxOlivia PEUCHANT, PharmD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959408
- Sponsor's protocol ID
- CHUBX 2022/52
- Acronym
- VISTH
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR) in Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT05959408
- Acronym / sponsor ID
- VISTH / CHUBX 2022/52
- Conditions
- Men Who Have Sex With Men
- Keywords
- Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, viability PCR, Nucleic acid amplification tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial STIs in MSM.
| Arm | Type | Receives |
|---|---|---|
| men who have sex with men | Experimental | Procedure: Collection of throat swab, Procedure: Collection of anal swab, Procedure: Collection of first void urine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of throat swabIntroduction of a cotton swab for self-collection | Procedure or surgery | men who have sex with men |
| Collection of anal swabIntroduction of a cotton swab for self-collection | Procedure or surgery | men who have sex with men |
| Collection of first void urinefirst void urine collected on urine pot | Procedure or surgery | men who have sex with men |
Primary outcome
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
Time frame: Day 1
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).
5 secondary outcomes
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.
Time frame: 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
Time frame: 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.
Time frame: Day 1
Ratio of bacterial load of viable bacteria to total bacterial load (viable and nonviable bacteria) in each specimen.
Time frame: 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.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles CAZANAVE, MD, PhD principal investigator
University Hospital, Bordeaux
Olivia PEUCHANT, PharmD study director
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of throat swab, Collection of anal swab and Collection of first void urine in people with Men Who Have Sex With Men, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivia PEUCHANT, PharmD (+335 56 79 56 67, olivia.peuchant@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.