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

NCT03568695 | Completed

• 1 other identifier: CHRO-2018-01
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 5

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).

Conditions

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

Keywords

pooled analysis; sensitivity; men who have sex with men

Outcome Measures

Primary Outcomes (1)

• 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%.

  Day 1

Secondary Outcomes (1)

• Impact of the strategies on the costs

  Day 1

Study Arms (1)

Detected patients

OTHER

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)

Interventions

Two samples on each of the three sites (pharynx, rectum, urine) DIAGNOSTIC_TEST

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 .

Detected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being under tutorship
• Being deprived of liberty

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (5)

CH de Niort

Niort, 79021, France

Location

CHR d'Orleans

Orléans, 45067, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CH Laennec

Quimper, 29107, France

Location

CHU de Tours

Tours, 37044, France

Location

Related Publications (5)

• Kacena KA, Quinn SB, Howell MR, Madico GE, Quinn TC, Gaydos CA. Pooling urine samples for ligase chain reaction screening for genital Chlamydia trachomatis infection in asymptomatic women. J Clin Microbiol. 1998 Feb;36(2):481-5. doi: 10.1128/JCM.36.2.481-485.1998.

  PMID: 9466763 BACKGROUND

• La Ruche G, Le Strat Y, Fromage M, Bercot B, Goubard A, de Barbeyrac B, Sednaoui P, Cambau E, Lot F. Incidence of gonococcal and chlamydial infections and coverage of two laboratory surveillance networks, France, 2012. Euro Surveill. 2015 Aug 13;20(32):6-15.

  PMID: 26290487 BACKGROUND

• Lewis JL, Lockary VM, Kobic S. Cost savings and increased efficiency using a stratified specimen pooling strategy for Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis. 2012 Jan;39(1):46-8. doi: 10.1097/OLQ.0b013e318231cd4a.

  PMID: 22183846 BACKGROUND

• Kacena KA, Quinn SB, Hartman SC, Quinn TC, Gaydos CA. Pooling of urine samples for screening for Neisseria gonorrhoeae by ligase chain reaction: accuracy and application. J Clin Microbiol. 1998 Dec;36(12):3624-8. doi: 10.1128/JCM.36.12.3624-3628.1998.

  PMID: 9817885 BACKGROUND

• Prazuck T, Lanotte P, Le Moal G, Hocqueloux L, Sunder S, Catroux M, Garcia M, Perfezou P, Gras G, Plouzeau C, Leveque N, Beby-Defaux A. Pooling Rectal, Pharyngeal, and Urine Samples to Detect Neisseria gonorrhoeae, Chlamydia trachomatis, and Mycoplasma genitalium Using Multiplex Polymerase Chain Reaction Is as Effective as Single-Site Testing for Men Who Have Sex With Men. Open Forum Infect Dis. 2022 Oct 31;9(10):ofac496. doi: 10.1093/ofid/ofac496. eCollection 2022 Oct.

  PMID: 36324326 DERIVED

MeSH Terms

Conditions

Gonorrhea; Hypersensitivity; Homosexuality

Interventions

Urination

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Thierry PRAZUCK, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: June 29, 2018
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

FR (5)