Prevention of Arrhythmia Device Infection Trial (PADIT)

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01628666
Study type	Interventional
Source	Population Health Research Institute
Contact
Status	Completed
Phase	Phase 4
Start date	December 2012
Completion date	September 8, 2017

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