Chlamydia Trachomatis Infection, Mycoplasma Genitalium Infection, Neisseria Gonorrheae Infection, Polymerase Chain Reaction, Sensitivity
Conditions
Keywords
pooled analysis, sensitivity, men who have sex with men
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTTwo samples on each of the three sites (pharynx, rectum, urine)
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 .
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the sensitivity of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection in a pooled analysis | Day 1 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the strategies on the costs | Day 1 | Costs will include time of lab staff, DNA extraction, PCR material in the two strategies and related to 1000 patients |
Countries
France
Outcome results
None listed