Prevention of Arrhythmia Device Infection Trial (PADIT)
NCT01628666 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12814
Last updated 2019-06-24
Summary
The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.
Conditions
Interventions
- DRUG
-
Incremental
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
- DRUG
-
Conventional
Cefazolin preoperative
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Population Health Research Institute
lead OTHER
Principal Investigators
-
Andrew Krahn, MD · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2017-09-08
- Completion
- 2017-09-08
Countries
- Canada
Study Locations
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