Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-09 @ 7:18 AM
Study NCT ID:
NCT04297592
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-03
First Post:
2020-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002506', 'term': 'Cephalexin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D002434', 'term': 'Cefadroxil'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4618}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periprosthetic joint infections', 'timeFrame': 'Within 90-days primary hip or knee arthroplasty', 'description': 'Defined by Musculoskeletal Infection Society (MSIS) criteria'}, {'measure': 'Periprosthetic joint infections', 'timeFrame': 'Within 1-year of primary hip or knee arthroplasty', 'description': 'Defined by Musculoskeletal Infection Society (MSIS) criteria'}], 'secondaryOutcomes': [{'measure': 'Wound complication', 'timeFrame': 'Within 90 days of primary hip or knee arthroplasty', 'description': 'Defined by at least one of the following: surgical wound dehiscence, skin necrosis at the surgical site, persistent surgical wound drainage (fluid extrusion from the operative site occurring beyond 72 hours from index surgery), superficial surgical site infection treated with new prescription of antibiotics or a change in study antibiotics but not meeting criteria for periprosthetic joint infection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total hip arthroplasty', 'total knee arthroplasty', 'hip replacement', 'knee replacement', 'periprosthetic joint infection', 'prophylaxis', 'antibiotics'], 'conditions': ['Infections Joint Prosthetic', 'Overweight or Obesity', 'MSSA Colonization', 'MRSA', 'Chronic Kidney Diseases', 'Diabetes', 'Autoimmune Diseases', 'Inflammatory Disease', 'Tobacco Use']}, 'referencesModule': {'references': [{'pmid': '30562290', 'type': 'BACKGROUND', 'citation': 'Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.'}, {'pmid': '28722231', 'type': 'BACKGROUND', 'citation': 'Li B, Webster TJ. Bacteria antibiotic resistance: New challenges and opportunities for implant-associated orthopedic infections. J Orthop Res. 2018 Jan;36(1):22-32. doi: 10.1002/jor.23656. Epub 2017 Aug 11.'}, {'pmid': '22554729', 'type': 'BACKGROUND', 'citation': 'Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.', 'detailedDescription': 'The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following elective, primary total hip and knee arthroplasty effectively decreases the risk of periprosthetic joint infection or wound complications following surgery in a patient population that is high-risk for these complications. Patient with one or more of the following risk factors are considered high-risk for periprosthetic joint infection and/or wound complications: body mass index over 35kg/m\\^2, diagnosis of diabetes, chronic kidney disease, active tobacco user, nasal colonization of methicillin-resistant Staphylococcus aureus and/or methicillin-sensitive Staphylococcus aureus, or autoimmune/inflammatory disease.\n\nStudy participants will be randomized to either a 7-day course of an oral, prophylactic antibiotic following surgery or no additional antibiotic. All other standard perioperative total joint arthroplasty care will remain the same for both groups, including 24-hours of perioperative antibiotics. Outcomes assessed will include surgical wound complications occurring within 90-day of surgery and periprosthetic joint infection occurring within 90-day and 1-year of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is a candidate for elective, primary total hip arthroplasties (THA) or total knee arthroplasties (TKA).\n* Patient is considered high-risk for developing Periprosthetic joint infections (PJI) based on having at least one of the following criteria:\n* Body mass index (BMI) \\> 35 kg/m\\^2;\n* Diagnosis of diabetes mellitus;\n* Active tobacco smoker;\n* Chronic kidney disease;\n* Autoimmune disease;\n* Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA).\n\nExclusion Criteria:\n\n* Inability to consume oral antibiotics.\n* Allergy to antibiotic alternatives in the protocol.\n* History of clostridium difficile colitis.\n* Revision hip or knee arthroplasty procedure.\n* Non-elective surgery.\n* Hemiarthroplasty.\n* Unicompartmental knee arthroplasty.\n* Simultaneous bilateral THA or TKA.\n* Will have subsequent THA or TKA within 12 weeks of the index study procedure.\n* Pregnant.'}, 'identificationModule': {'nctId': 'NCT04297592', 'briefTitle': 'Antibiotic Prophylaxis in High-Risk Arthroplasty Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Antibiotic Prophylaxis in High-Risk Arthroplasty Patients', 'orgStudyIdInfo': {'id': '22-001273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Additional Antibiotic Group', 'description': 'Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.', 'interventionNames': ['Drug: Cephalexin', 'Drug: Doxycycline', 'Drug: Cefadroxil']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - No Additional Antibiotic', 'description': 'Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.'}], 'interventions': [{'name': 'Cephalexin', 'type': 'DRUG', 'otherNames': ['Keflex'], 'description': '500 mg oral tablet, 4 times daily for 7 days', 'armGroupLabels': ['Additional Antibiotic Group']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': '100 mg oral tablet, 2 times daily for 7 days', 'armGroupLabels': ['Additional Antibiotic Group']}, {'name': 'Cefadroxil', 'type': 'DRUG', 'otherNames': ['Duricef'], 'description': '500 mg oral tablet, 2 times daily for 7 days', 'armGroupLabels': ['Additional Antibiotic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Nicholas Bedard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicholas A. Bedard', 'investigatorAffiliation': 'Mayo Clinic'}}}}