Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-01 @ 4:51 PM
Study NCT ID:
NCT04954495
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-29', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical forms of these anorectal infection', 'timeFrame': 'Day 1', 'description': 'This outcome corresponds to the clinical presentation : prevalence of clinical signs \\[fever (Yes/no), ulcerations (yes/no), purulent proctisis (yes/no), erythematosus proctisis (yes/no), condyloma (yes/no)\\].'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anorectal Infection']}, 'referencesModule': {'references': [{'pmid': '23813703', 'type': 'BACKGROUND', 'citation': 'Price MJ, Ades AE, De Angelis D, Welton NJ, Macleod J, Soldan K, Simms I, Turner K, Horner PJ. Risk of pelvic inflammatory disease following Chlamydia trachomatis infection: analysis of prospective studies with a multistate model. Am J Epidemiol. 2013 Aug 1;178(3):484-92. doi: 10.1093/aje/kws583. Epub 2013 Jun 27.'}, {'pmid': '28692536', 'type': 'BACKGROUND', 'citation': 'Vieira VA, Avelino-Silva VI, Cerqueira NB, Costa DA, Costa PR, Vasconcelos RP, Madruga VR, Moreira RI, Hoagland B, Veloso VG, Grinsztejn B, Kallas EG; PrEP Brasil Study Team. Asymptomatic anorectal Chlamydia trachomatis and Neisseria gonorrhoeae infections are associated with systemic CD8+ T-cell activation. AIDS. 2017 Sep 24;31(15):2069-2076. doi: 10.1097/QAD.0000000000001580.'}], 'seeAlsoLinks': [{'url': 'https://www.ecdc.europa.eu/en/publications-data/chlamydia-control-europe-literature-review', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Infectious anorectitis is a poorly described clinical entity. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly made in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.\n\nThe proctology center of the Marie Thérèse Center is the leading proctology center in the Ile-de-France region both in terms of recruitment and reputation, and drains a large proportion of patients with anorectitis for specialized care. The clinical microbiology laboratory of the Saint Joseph Hospital Group is linked to the Marie Thérèse Center to provide its expertise in the microbiological and infectious aspects of the management of these infections.\n\nIn recent years, the analysis of data from this large population of patients referred to the Léopold Bellan proctology center for suspected ano-rectitis has revealed the pathogens Neisseria gonorrhoeae and/or Chlamydia trachomatis.\n\nMycoplasma genitalium (MG) is an emerging pathogen responsible for Sexually Transmitted Infections (STI) and has been described increasingly in recent years. Studies on this pathogen will allow to better identify risk factors and to target optimized prevention and therapeutic management strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Patient whose age is ≥ 18 year, treated at the Centre de proctologie of the Centre de santé Marie-Thérèse or the GHPSJ (consultation and/or hospitalization) and for whom an anorectal swab will be taken for suspected infectious sexually transmitted ano-rectitis from June 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient whose age is ≥ 18 years\n* Patients treated at the Centre de proctologie of the Centre de santé Marie-Thérèse or the GHPSJ (consultation and/or hospitalization) and for whom an anorectal swab will be taken for suspected infectious sexually transmitted ano-rectitis\n* French-speaking patient\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under court protection\n* Patient objecting to the use of his data for this research'}, 'identificationModule': {'nctId': 'NCT04954495', 'acronym': 'IST_MG', 'briefTitle': 'Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects', 'orgStudyIdInfo': {'id': 'IST_MG'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Lourtet', 'role': 'CONTACT', 'email': 'jlourtet@ghpsj.fr', 'phone': '144127420', 'phoneExt': '+33'}], 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Julie LOURTET', 'role': 'CONTACT', 'email': 'jlourtet@ghpsj.fr', 'phone': '144127420', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Julie Lourtet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}