Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-22 @ 9:29 PM
Study NCT ID:
NCT05421312
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017218', 'term': 'Cordocentesis'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This explorative, low intervention study will be conducted in the Radboudumc Nijmegen and Sint Maartenskliniek (SMK) Nijmegen, The Netherlands.\n\nSubject will receive the cefazolin antibiotic prophylaxis and clindamycin antibiotic therapy as standard of care. The study interventions will include blood sampling on baseline and perioperative sampling of serum, synovial fluid and bone for the concentration measurements of the antibiotic agents. For every participating subject 3 serum samples, 1 synovial fluid sample and 2 bone samples will be taken for concentration measurement of cefazolin and clindamycin. Samples will be taken at different timepoints during the procedure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'penetration cefazolin into synovial fluid', 'timeFrame': 'during surgical procedure prior to incision the synovial fluid sample will be taken', 'description': 'The ratio (%) of the concentration of cefazolin in synovial fluid to serum.'}, {'measure': 'penetration cefazolin into bone tissue', 'timeFrame': 'during surgical procedure prior to incision the synovial fluid sample will be taken', 'description': 'The ratio (%) of the concentration of cefazolin in synovial fluid to serum.'}, {'measure': 'penetration clindamycin into bone tissue', 'timeFrame': 'during surgical procedure, directly after opening the joint and before reimplantation of the prosthesis the bone samples will be taken', 'description': 'The ratio (%) of the concentration of cefazolin in bone tissue to serum.'}], 'secondaryOutcomes': [{'measure': 'AUC/MIC90 of cefazolin', 'timeFrame': 'sampling during procedure', 'description': 'The ratio of area under the curve of cefazolin to the minimal inhibitory concentration-90 of microorganisms'}, {'measure': 'AUC/MIC90 of clindamycin', 'timeFrame': 'sampling during procedure', 'description': 'The ratio of area under the curve of cefazolin to the minimal inhibitory concentration-90 of microorganisms'}, {'measure': 'factors associated with reduced cefazolin concentration', 'timeFrame': 'sampling during procedure', 'description': 'univariable and multivariable (if possible) analysis for factors that are associated with reduced concentration of cefazolin (i.e., BMI, age, ..)'}, {'measure': 'factors associated with reduced clindamycin concentration', 'timeFrame': 'sampling during procedure', 'description': 'univariable and multivariable (if possible) analysis for factors that are associated with reduced concentration of cefazolin (i.e., BMI, age, ..)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PJI', 'Bone and Joint Infection', 'Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.', 'detailedDescription': 'Periprosthetic joint infection (PJI) is a feared complication of joint replacement, with an incidence of 0.5-1% after primary joint replacement and 3-5% after revision arthroplasty. For orthopaedic surgery involving a prosthesis, the administration of systemic antibiotic prophylaxis is strongly recommended to prevent PJI. Cefazolin is widely used as agent of choice in surgical antibiotic prophylaxis. Previous studies, all performed in patients undergoing primary joint replacement, demonstrated that the concentration of cefazolin in bone and synovial fluid was dose-dependent and exceeds the MIC90 for methicillin susceptible Staphylococcus aureus (MSSA), when given as 1 to 4 gram single dose shortly before incision. When a PJI is already present, clindamycin is used as treatment option in PJI caused by staphylococci (when combined with rifampicin) or cutibacteria. A limited number of studies have been performed to analyse the penetration of clindamycin into bone. These studies showed that clindamycin penetrates well into the bone and concentrations exceeded the MIC90 for MSSA. No studies have been performed to analyse the penetration of antibiotic agents into the periarticular tissue in patients who will undergo revision arthroplasty. In revision arthroplasty a foreign body (prosthesis) is in situ and periarticular tissue condition can be compromised due to previous surgical procedures and the presence of bone reaction to the prosthesis. It is not known whether the difference in PJI incidence after primary and revision arthroplasty may be explained by different penetration of the surgical antibiotic prophylaxis. The aim of this explorative study is to analyse the penetration of cefazolin and clindamycin into synovial fluid and bone and whether the concentration of the agents exceeds the MIC90 for micro-organisms frequently causing PJI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 16 years or older.\n2. Scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis during clindamycin 600mg three times a day orally for PJI, started at least 3 days before reimplantation (steady state).\n\nExclusion Criteria:\n\n1. Antibiotic prophylaxis other than cefazolin 2000mg i.v.\n2. Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision.\n3. Clindamycin loaded bone cement in situ.\n4. BMI more than 35 kg/m2.'}, 'identificationModule': {'nctId': 'NCT05421312', 'acronym': 'CONCENTRATE', 'briefTitle': 'Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip', 'orgStudyIdInfo': {'id': '2022-13583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cefazolin', 'description': 'The cefazolin antimicrobial prophylaxis (2000mg single dose intravenously 15-60 minutes before incision) is part of standard of care.', 'interventionNames': ['Drug: sampling blood', 'Drug: Sampling synovial fluid', 'Drug: Sampling bone tissue']}, {'type': 'OTHER', 'label': 'Clindamycin', 'description': 'The clindamycin (600mg three times daily orally) PJI therapy is part of standard care.', 'interventionNames': ['Drug: sampling blood', 'Drug: Sampling synovial fluid', 'Drug: Sampling bone tissue']}], 'interventions': [{'name': 'sampling blood', 'type': 'DRUG', 'description': 'During the reimplantation, 3 serum samples will be taken at different timepoint during the procedure.', 'armGroupLabels': ['Clindamycin', 'cefazolin']}, {'name': 'Sampling synovial fluid', 'type': 'DRUG', 'description': 'During the reimplantation 1 synovial fluid sample will be taken prior to incision.', 'armGroupLabels': ['Clindamycin', 'cefazolin']}, {'name': 'Sampling bone tissue', 'type': 'DRUG', 'description': 'During the reimplantation 2 cortical bone samples will be taken at different timepoints during the procedure.', 'armGroupLabels': ['Clindamycin', 'cefazolin']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karin Veerman, MD', 'role': 'CONTACT', 'email': 'karin.veerman@radboudumc.nl', 'phone': '+31683845606'}], 'overallOfficials': [{'name': 'Nynke Jager, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Jon Goosen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint Maartenskliniek'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sint Maartenskliniek', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}