- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03568695
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)
August 31, 2020 updated by: Centre Hospitalier Régional d'Orléans
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
166
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Niort, France, 79021
- CH de Niort
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Orléans, France, 45067
- CHR d'Orléans
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Poitiers, France, 86000
- CHU de Poitiers
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Quimper, France, 29107
- CH Laennec
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Tours, France, 37044
- CHU de Tours
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Detected patients
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 .
|
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the sensitivity of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection in a pooled analysis
Time Frame: 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%.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the strategies on the costs
Time Frame: Day 1
|
Costs will include time of lab staff, DNA extraction, PCR material in the two strategies and related to 1000 patients
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thierry PRAZUCK, Dr, CHR d'Orléans
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2018
Primary Completion (Actual)
June 16, 2020
Study Completion (Actual)
June 16, 2020
Study Registration Dates
First Submitted
June 14, 2018
First Submitted That Met QC Criteria
June 14, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Sexually Transmitted Diseases
- Immune System Diseases
- Pneumonia
- Lung Diseases
- Disease Attributes
- Pleural Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Pleurisy
- Mycoplasmatales Infections
- Hypersensitivity
- Infections
- Communicable Diseases
- Chlamydia Infections
- Gonorrhea
- Pleuropneumonia
- Mycoplasma Infections
Other Study ID Numbers
- CHRO-2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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