Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-10 @ 11:53 AM
Study NCT ID:
NCT03568695
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2018-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the sensitivity of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection in a pooled analysis', 'timeFrame': 'Day 1', '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%.'}], 'secondaryOutcomes': [{'measure': 'Impact of the strategies on the costs', 'timeFrame': 'Day 1', 'description': 'Costs will include time of lab staff, DNA extraction, PCR material in the two strategies and related to 1000 patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pooled analysis', 'sensitivity', 'men who have sex with men'], 'conditions': ['Chlamydia Trachomatis Infection', 'Neisseria Gonorrheae Infection', 'Mycoplasma Genitalium Infection', 'Sensitivity', 'Polymerase Chain Reaction']}, 'referencesModule': {'references': [{'pmid': '9466763', 'type': 'BACKGROUND', '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.'}, {'pmid': '26290487', 'type': 'BACKGROUND', '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.'}, {'pmid': '22183846', 'type': 'BACKGROUND', '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.'}, {'pmid': '9817885', 'type': 'BACKGROUND', '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.'}, {'pmid': '36324326', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having provided a written consent;\n* Patient age \\> 18 years;\n* Man who have sex with men tested positive for one the three STIs : Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma genitalium\n* Covered by health insurance\n\nExclusion Criteria:\n\n* Being under tutorship\n* Being deprived of liberty\n* Patient who received antibiotic treatment prior to study inclusion and re-sampling'}, 'identificationModule': {'nctId': 'NCT03568695', 'acronym': 'ISTPOOL', 'briefTitle': 'Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CHRO-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Detected patients', '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 .', 'interventionNames': ['Diagnostic Test: Two samples on each of the three sites (pharynx, rectum, urine)']}], 'interventions': [{'name': 'Two samples on each of the three sites (pharynx, rectum, urine)', 'type': 'DIAGNOSTIC_TEST', '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 .', 'armGroupLabels': ['Detected patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79021', 'city': 'Niort', 'country': 'France', 'facility': 'CH de Niort', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': "CHR d'Orleans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'CH Laennec', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Thierry PRAZUCK, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHR d'Orléans"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}