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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)

Primary Purpose

Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Mycoplasma Genitalium Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Two samples on each of the three sites (pharynx, rectum, urine)
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chlamydia Trachomatis Infection focused on measuring pooled analysis, sensitivity, men who have sex with men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • CH de Niort
  • CHR d'Orleans
  • CHU de Poitiers
  • CH Laennec
  • CHU de Tours

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Detected patients

Arm 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 .

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2018
Last Updated
August 31, 2020
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03568695
Brief Title
Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples
Acronym
ISTPOOL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Mycoplasma Genitalium Infection, Sensitivity, Polymerase Chain Reaction
Keywords
pooled analysis, sensitivity, men who have sex with men

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Detected patients
Arm Type
Other
Arm 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 .
Intervention Type
Diagnostic Test
Intervention Name(s)
Two samples on each of the three sites (pharynx, rectum, urine)
Intervention Description
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 Measure Information:
Title
To evaluate the sensitivity of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection in a pooled analysis
Description
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
Secondary Outcome Measure Information:
Title
Impact of the strategies on the costs
Description
Costs will include time of lab staff, DNA extraction, PCR material in the two strategies and related to 1000 patients
Time Frame
Day 1

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PRAZUCK, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH de Niort
City
Niort
ZIP/Postal Code
79021
Country
France
Facility Name
CHR d'Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CH Laennec
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
9466763
Citation
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.
Results Reference
background
PubMed Identifier
26290487
Citation
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.
Results Reference
background
PubMed Identifier
22183846
Citation
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.
Results Reference
background
PubMed Identifier
9817885
Citation
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.
Results Reference
background
PubMed Identifier
36324326
Citation
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.
Results Reference
derived
Links:
URL
https://cns.sante.fr/wp-content/uploads/2017/10/experts-vih_aes.pdf
Description
Rapport Morlat 2017

Learn more about this trial

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

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