Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-30 @ 2:20 PM
Study NCT ID:
NCT01613092
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2012-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Arrhythmia Device Infection Trial (PADIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D001414', 'term': 'Bacitracin'}, {'id': 'D002506', 'term': 'Cephalexin'}, {'id': 'D002981', 'term': 'Clindamycin'}], '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': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization attributed to device infection', 'timeFrame': 'within one year of device procedure', 'description': 'Hospitalization attributed to device infection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Device Procedure', 'High risk patients', 'Antibiotics', 'Infection', 'Cluster'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).', 'detailedDescription': 'Multi-center, cluster crossover, unblinded, pilot study. Centers will be randomized to conventional vs. incremental antibiotic therapy for 2 months or until eligible 20 patients are treated, whichever comes first. At 2 months, centers will have a crossover period of 4 weeks where the alternate strategy is implemented, followed by the final 2-month/20 patient enrolment period. During each treatment period the randomized antibiotic strategy will be used on all center patients undergoing a device implant procedure. Prior to the planned surgery or at the first follow up visit, patients who meet the study eligibility criteria will be approached to obtain consent for data collection purposes. Follow up will be according to usual clinical care at the center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* received one of the following procedures:\n\n 1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)\n 2. new cardiac resynchronization therapy device implant (pacemaker or ICD)\n\nExclusion Criteria:\n\n* life expectancy \\< 12 months in the opinion of the local investigator.\n* allergy or unable to tolerate cefazolin or clindamycin or vancomycin.\n* allergy or unable to tolerate intracavitary bacitracin identified per-operatively.\n* pre-operative identification that the patient has infection.'}, 'identificationModule': {'nctId': 'NCT01613092', 'briefTitle': 'Prevention of Arrhythmia Device Infection Trial (PADIT)', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study', 'orgStudyIdInfo': {'id': 'PADIT Cluster Crossover Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional', 'description': 'Preoperative Antibiotics', 'interventionNames': ['Drug: Cefazolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aggressive (Incremental)', 'description': 'Preoperative antibiotics, antibiotic wash and post operative antibiotics', 'interventionNames': ['Drug: Incremental']}], 'interventions': [{'name': 'Incremental', 'type': 'DRUG', 'otherNames': ['Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin'], 'description': 'Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin', 'armGroupLabels': ['Aggressive (Incremental)']}, {'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Preoperative antibiotic', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital, McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Dr. Andrew Krahn, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}