Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples

Study Overview
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Brief Summary
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This study aims to compare the sensitivity of detecting Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by real-time multiplex PCR in a pooled analysis (i.e. gathering pharyngeal, anorectal and urinary samples) versus the standard of care (where a real-time multiplex PCR is made in each of the three samples).

Detailed Description
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Patients detected positive for one of the three (Sexually Transmitted Infection)STIs (Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma genitalium) on one site will be re-sampled twice at each of the three sites (pharynx, rectum, urine) before receiving antibiotics. Then, a real-time multiplex PCR will be performed on the pooled sample (merging pharyngeal, anorectal and urinary samples) versus on each of the three samples separately (i.e. standard of care) to compare both sensitivities.

Official Title
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Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction After Pooling Pharyngeal, Anorectal and Urinary Samples, in Men Who Have Sex With Men

Conditions
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Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Mycoplasma Genitalium Infection, Sensitivity, Polymerase Chain Reaction

Intervention / Treatment
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* Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient having provided a written consent; Patient age > 18 years; Man who have sex with men tested positive for one the three STIs : Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma genitalium Covered by health insurance Exclusion Criteria: Being under tutorship Being deprived of liberty Patient who received antibiotic treatment prior to study inclusion and re-sampling

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Detected patients<br>If they agree to participate in the study, the patients detected for one or the other of the STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium) on one site, will have on day of result return, two new samples on each of the three sites (pharynx, rectum, urine) which will make it possible to compare the difference of sensitivity between real-time multiplex PCR from pools of 3 samples and the usual technique . | Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine)<br>* two new samples on each of the three sites (pharynx, rectum, urine) which will make it possible to compare the difference of sensitivity between real-time multiplex PCR from pools of 3 samples and the usual technique .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the sensitivity of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection in a pooled analysis | Sensitivity rates will be compared using non parametric statistical analysis. The pooling method will be considered as acceptable if the sensitivity reach at least 95%. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the strategies on the costs | Costs will include time of lab staff, DNA extraction, PCR material in the two strategies and related to 1000 patients | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pooled analysis, sensitivity, men who have sex with men