NCT01628666

Prevention of Arrhythmia Device Infection Trial (PADIT)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12,814 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. Centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. Patients will not be randomized. Centres will be randomized to one therapy and then cross over to the next after 6 months. At one year they will randomize again and then cross over for the final time at 18 months. During each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure. Ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). A third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).

Conditions

• Arrhythmia

Interventions

Type	Name	Description
DRUG	Incremental	Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
DRUG	Conventional	Cefazolin preoperative

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-09-08
• Completion: 2017-09-08
• First posted: 2012-06-27
• Last updated: 2019-06-24

Locations

1 site across 1 country: Canada