Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Bacitracin; Cefazolin; Cephalexin

Criteria

Inclusion Criteria:

• > 18 years

• One of the following planned device procedures:

• ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement or

• Pocket or lead revision or

• System upgrade (insertion or attempted insertion of leads) or

• New cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion Criteria:

• Unable or unwilling to provide written informed consent

• Unable or unwilling to complete the study follow-up schedule

• Life expectancy < 12 months as per the opinion if the local investigator

• Allergy to or unable to tolerate cefazolin or clindamycin or vancomycin

• Allergy to or unable to tolerate intracavitary bacitracin or gentamicin or cefazolin

• Previously enrolled in this trial

• In another study that would confound the results of this trial