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

Not Applicable

Completed

• Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection; Sensitivity; Polymerase Chain Reaction; Mycoplasma Genitalium Infection
• Interventions: Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine)

• Registration Number: NCT03568695
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-26
• Study Start: 2018-06-29
• Primary Completion: 2020-06-16
• Study Completion: 2020-06-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 166

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

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Exclusion Criteria

• Being under tutorship
• Being deprived of liberty
• Patient who received antibiotic treatment prior to study inclusion and re-sampling

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Detected patients	Two samples on each of the three sites (pharynx, rectum, urine)	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 .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

CH de Niort; 🇫🇷 Niort, France

CHR d'Orleans; 🇫🇷 Orléans, France

CHU de Tours; 🇫🇷 Tours, France

CH Laennec; 🇫🇷 Quimper, France

CHU de Poitiers; 🇫🇷 Poitiers, France