Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-01 @ 9:58 AM
Study NCT ID:
NCT04409392
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2020-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staphylococcus Lugdunensis Prosthetic Joint Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of PJI infection with Staphylococcus lugdunensis', 'timeFrame': 'between 2010 and 2020', 'description': 'proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria'}, {'measure': 'Description of PJI infection with Staphylococcus lugdunensis : type', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'type of PJI : knee or hip prosthesis'}, {'measure': 'Description of PJI infection with Staphylococcus lugdunensis : evolution', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'evolution of PJI :evolution between prosthesis placement and the onset of symptoms, gateway to infection'}, {'measure': 'Description of patients with PJI infection due to Staphylococcus lugdunensis', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'type of patients: age, CMI'}, {'measure': 'Description of patients with PJI infection due to Staphylococcus lugdunensis : follow up', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'duration of the follow up of patients'}, {'measure': 'Description of patients with PJI infection due to Staphylococcus lugdunensis : medical treatment', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'description and duration of antibiotics'}, {'measure': 'Description of patients with PJI infection due to Staphylococcus lugdunensis : surgical treatment', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'description of surgery performed : DAIR, one-step exchange, two-step exchange'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Staphylococcus lugdunensis', 'Prosthetic Joint Infection', 'biofilm'], 'conditions': ['Staphylococcal Infections', 'Prosthetic Joint Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.crioac-lyon.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human commensal cutaneous flora, and has been little studied in the field of prosthetic joint infections. However, it shares many virulence traits with Staphylococcus aureus, including many adhesins and its ability to form biofilm, and the few series of cases reports a significant failure rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having had IPA due to Staphylococcus lugdunensis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infection of joint prosthesis (whatever its type) with Staphylococcus lugdunensis defined by the positivity of at least 2 gold-standard samples (joint puncture, intraoperative samples) with S. lugdunensis; OR\n* a single positive gold-standard sample or positive blood cultures AND formal clinical, radiological, biological and / or pathological arguments in favor of an infection of joint prosthesis AND absence of other pathogenic agent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04409392', 'briefTitle': 'Staphylococcus Lugdunensis Prosthetic Joint Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '20-202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prothestic joint infection due to Staphylococcus lugdunensis', 'description': 'Patients having had a prosthetic joint infection with Staphylococcus lugdunensis', 'interventionNames': ['Other: Prothestic joint infection due to Staphylococcus lugdunensis']}], 'interventions': [{'name': 'Prothestic joint infection due to Staphylococcus lugdunensis', 'type': 'OTHER', 'description': 'description of prosthetic joint infection with Staphylococcus lugdunensis', 'armGroupLabels': ['Prothestic joint infection due to Staphylococcus lugdunensis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}