Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT03796104
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D000088562', 'term': 'Persistent Infection'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025994', 'term': 'delta hemolysin protein, Staphylococcus aureus'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups'}], 'secondaryOutcomes': [{'measure': 'Rate of Treatment Failure', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor. Comparison between the 2 groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone and Joint Infection', 'Staphylococcus Aureus', 'chronic infection'], 'conditions': ['Bone and Joint Infection', 'Staphylococcus Aureus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having implant infection due to S. aureus treated by DAIR managed at the Lyon Bone and joint infection reference Center between 2006 and 2018', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients having implant infection due to S. aureus treated by DAIR\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03796104', 'briefTitle': 'Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR', 'orgStudyIdInfo': {'id': '18-333'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Deficiency of delta-hemolysine', 'description': 'Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency', 'interventionNames': ['Other: Delta-haemolysin']}, {'label': 'Presence of delta-hemolysine', 'description': 'Implant infected by Staphylococcus aureus with delta-haemolysin Production', 'interventionNames': ['Other: Delta-haemolysin']}], 'interventions': [{'name': 'Delta-haemolysin', 'type': 'OTHER', 'description': 'comparison of groups having infection with S. aureus with and without delta-haemolysin Production', 'armGroupLabels': ['Deficiency of delta-hemolysine', 'Presence of delta-hemolysine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eugenie Mabrut, CRA', 'role': 'CONTACT'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Johanna Boulant, CRA', 'role': 'CONTACT', 'email': 'johanna.boulant@chu-lyon.fr'}], 'overallOfficials': [{'name': 'FLORENT VALOUR, Md,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical research assistant', 'investigatorFullName': 'Eugénie MABRUT', 'investigatorAffiliation': 'Hospices Civils de Lyon'}}}}