NCT01613092

Prevention of Arrhythmia Device Infection Trial (PADIT)

Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Arrhythmia

Interventions

Type	Name	Description
DRUG	Incremental	Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
DRUG	Cefazolin	Preoperative antibiotic

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-06-06
• Last updated: 2014-10-10

Locations

2 sites across 1 country: Canada