Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04409769
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2020-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C443755', 'term': 'ceftobiprole'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of use of ceftaroline and ceftobiprole : patients', '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': 'Evaluation of use of ceftaroline: dosage', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'dosage,duration'}, {'measure': 'Evaluation of use of ceftaroline : PJI/BJI', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'description of the PJI/BJI treated by ceftaroline : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection'}, {'measure': 'Evaluation of use of ceftobiprole: dosage', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'dosage, duration'}, {'measure': 'Evaluation of use of ceftobiprole: PJI/BJI', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'description of the PJI/BJI treated by ceftobiprole : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection'}, {'measure': 'rate of failure under ceftaroline', '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'}, {'measure': 'rate of failure under ceftobiprole', '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'}], 'secondaryOutcomes': [{'measure': 'Treatment-related adverse events', 'timeFrame': '2 months', 'description': 'description of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone and joint infection', 'prosthesis joint infection', 'adverse event', 'ceftaroline', 'ceftobiprole'], 'conditions': ['Bone and Joint Infection', 'Antibiotic Reaction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.crioac-lyon.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the use of a glycopeptide, and most frequently vancomycin, as the anti-gram positive agent in empirical therapy, while awaiting the microbiological results. Vancomycin is not considered as a safe antibiotic, and daptomycin is frequently an alternative option.\n\nCeftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. As some data report a synergistic activity with daptomycin, they could be an option in pandrug-resistant staphylococci BJI, but their use if off label in this indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole treated at CRIOAc Lyon', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04409769', 'briefTitle': 'Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the Tolerance of Anti-MRSA Betalactamines (Ceftaroline / Ceftobiprole) in the Management of BJI / PJI: a Retrospective Study in a Reference Center', 'orgStudyIdInfo': {'id': '20-157'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Description of use of ceftaroline and ceftobiprole', 'description': 'description of patients and their PJI/BJI,conditions of use, adverse event', 'interventionNames': ['Other: Description of use of ceftaroline and ceftobiprole']}], 'interventions': [{'name': 'Description of use of ceftaroline and ceftobiprole', 'type': 'OTHER', 'description': 'Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI', 'armGroupLabels': ['Description of use of ceftaroline and ceftobiprole']}]}, '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'}}}}