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Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection (PADIT)
The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk patients undergoing arrhythmia device procedures. All antibiotics are approved for use and readily available.
Details
| Lead sponsor | Population Health Research Institute |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 500 |
| Start date | 2009-12 |
| Completion | 2012-01 |
Conditions
- Arrythmias
Interventions
- Cefazolin, Bacitracin, Cefalexin
- Cefazolin
Primary outcomes
- Hospitalization attributed to device infection. — Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur.
Countries
Canada