Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 3:23 AM
Study NCT ID:
NCT04902560
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2021-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate to Ceftriaxone 1g IM in Gonorrhoea.', 'timeFrame': 'day 1', 'description': 'Evaluated by a test of cure (TOC) which must be negative 15 days after the subject received the treatment (ceftriaxone).'}], 'secondaryOutcomes': [{'measure': 'Adverse drug reaction rates', 'timeFrame': 'day 1', 'description': 'Any adverse effect after treatment will be notified (digestive disorder, headache, phototoxicity, allergic reaction, local reaction at the site of injection…)'}, {'measure': 'Concordance rate with positive PCR', 'timeFrame': 'day 1', 'description': 'Before getting the treatment, all patients should have been sampled for bacterial culture according to current recommendation. Respect of the recommendation will be assessed by this outcome.'}, {'measure': 'Resistance rate to ceftriaxone and AMR description.', 'timeFrame': 'day 1', 'description': 'This measure will be assessed via bacterial cultures'}, {'measure': 'Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)', 'timeFrame': 'day 1', 'description': 'Patient compliance may be lacking in sexual health center and non-compliance participate in STI spreading.\n\nSubject not looking for their results after being tested positive for gonorrhea will be notified by phone call. The necessity of calling the patient will be notified in the study.\n\nIf the subject does not attend the medical consultation for treatment, he will be consider as lost to follow-up.'}, {'measure': 'Rate of realized TOC', 'timeFrame': 'day 1', 'description': 'Test of cure (TOC) is a PCR test realized at the previous positive site of contamination, approximately 14 days after treatment, in order to confirm the efficacity of treatment.'}, {'measure': 'Rate of time before realizing the TOC.', 'timeFrame': 'day 1', 'description': 'Sensibility and Specifity may differ depending on the time between treatment and the TOC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neisseria gonorrhoea', 'Ceftriaxone', 'Treatment'], 'conditions': ['Gonorrhea']}, 'descriptionModule': {'briefSummary': 'Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.\n\nPatients wanting STI screening can consult either they are symptomatic or not.\n\nIf they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.\n\nBefore any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.\n\nAfter every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.\n\nResponse rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.\n\nCompliance to current recommandation at CeGIDD Montpellier has never been evaluated.\n\nThis study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Aged more than 18 years old\n* Non-opposition form given to the subject\n* Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier\n\nExclusion criteria:\n\n\\- patient's refusal to participate"}, 'identificationModule': {'nctId': 'NCT04902560', 'acronym': 'GONOCEF', 'briefTitle': 'Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study', 'orgStudyIdInfo': {'id': 'RECHMPL21_0301'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Du Thanh Aurelie', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}