An interventional study of Two samples on each of the three sites (pharynx, rectum, urine) in Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection and Mycoplasma Genitalium Infection, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 5 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-01.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Diagnostic
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).
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 166 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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)
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 .
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%.
Time frame: Day 1
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
Time frame: Day 1
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Régional d'Orléans