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

Centre Hospitalier Régional d'Orléans

Status: Completed

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

Treatments: Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine)

Study type: Interventional

Funder types: Other

Identifiers

NCT03568695

CHRO-2018-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 166 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

Detected patients

Other group

Description:

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 .

Treatment:

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