Trials / Completed
CompletedNCT03568695
Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 166 (actual)
- Sponsor
- Centre Hospitalier Régional d'Orléans · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Chlamydia Trachomatis Infection
- Neisseria Gonorrheae Infection
- Mycoplasma Genitalium Infection
- Sensitivity
- Polymerase Chain Reaction
Interventions
| Type | Name | Description |
|---|---|---|
| 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 . |
Timeline
- Start date
- 2018-06-29
- Primary completion
- 2020-06-16
- Completion
- 2020-06-16
- First posted
- 2018-06-26
- Last updated
- 2020-09-01
Locations
5 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03568695. Inclusion in this directory is not an endorsement.