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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)

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ClinicalTrials.gov Identifier: NCT03568695
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Chlamydia Trachomatis Infection Neisseria Gonorrheae Infection Mycoplasma Genitalium Infection Sensitivity Polymerase Chain Reaction Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : June 16, 2020
Actual Study Completion Date : June 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Neisseria

Arm Intervention/treatment
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 .
Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine)
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 :
  1. 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%.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568695


Locations
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France
CH de Niort
Niort, France, 79021
CHR d'Orleans
Orléans, France, 45067
CHU de Poitiers
Poitiers, France, 86000
CH Laennec
Quimper, France, 29107
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Thierry PRAZUCK, Dr CHR d'Orléans
Additional Information:
Publications:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03568695    
Other Study ID Numbers: CHRO-2018-01
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
pooled analysis
sensitivity
men who have sex with men
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Chlamydia Infections
Gonorrhea
Mycoplasma Infections
Pleuropneumonia
Hypersensitivity
Immune System Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Neisseriaceae Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections