Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-01 @ 11:25 AM
Study NCT ID:
NCT02860767
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016459', 'term': 'Prosthesis-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measure was the evaluation of concentrations in serum and periprosthetic tissues of antibiotic agents used as empirical therapy during reimplantation of the infected prosthesis', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome will analyze the ratio of antibiotic concentration in serum and prosthetic tissues to minimum inhibitory concentration of the concerned antibiotic for the pathogen(s) identified in intraoperative samples', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prosthesis-Related Infections', 'Antibiotic dosing', 'Reimplantation', 'Knee-prothesis', 'Hip-prothesis'], 'conditions': ['Prosthesis-Related Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses', 'detailedDescription': 'The purpose of the study is to evaluate the concentrations of antibiotics (daptomycin, vancomycin, cefotaxime, ceftriaxone, cefepime) in serum and periprosthetic tissues(bone and synovial joint) used as empirical treatment during reimplantation of infected hip and knee prostheses (1-stage or 2-stage management).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with hip and knee prostheses infections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (aged of 18 years or more) who undergo reimplantation surgery for infected hip or knee prosthesis (performed in 1 or 2-stage(s)), and for whom referral physicians plans to use an empirical antibiotic therapy including cefotaxime, ceftriaxone, cefepime, daptomycin, or vancomycin.\n\nExclusion Criteria:\n\n* Patients with multiple prosthetic joint infections, or with curative antibiotic therapy ongoing within two weeks or less prior to surgery, or for whom an antibiotic prophylaxis is decided by referral for the reimplantation surgery, or for whom an antibiotic-loaded cement containing the same antibiotic chosen for empirical therapy after reimplantation was used in case of 2-stage exchange'}, 'identificationModule': {'nctId': 'NCT02860767', 'acronym': 'DOSOS', 'briefTitle': 'Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'Tourcoing Hospital'}, 'officialTitle': 'Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses', 'orgStudyIdInfo': {'id': '2013-000889-11'}}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'facility': 'Dron Hospital', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Eric M Senneville, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dron Hospital Tourcoing France'}, {'name': 'Sophie Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dron Hospital Tourcoing France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tourcoing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}