Prevention of Arrhythmia Device Infection Trial (PADIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Drug: Conventional; Drug: Incremental

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).

• Study Type: Interventional
• Enrollment (Actual): 12814
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Coordinating Centre: Population Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >= 18 years

2. Received one of the following procedures:

   1. A second or subsequent procedure on the arrhythmia device pocket:

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

   2. Pocket or lead revision
   3. System upgrade (insertion or attempted insertion of leads)
   4. New cardiac resynchronization therapy device implant (pacemaker or ICD)
3. Patient is not known to have device infection at the time of the surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional; Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.	Drug: Conventional; Cefazolin preoperative; Other Names: Cefazolin
Experimental: Incremental; Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.	Drug: Incremental; Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.; Other Names: Cefazolin; Vancomycin; Bacitracin; Cefalexin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospitalization attributed to device infection	Evaluation is one year post patient's procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Proven device infection not requiring surgical intervention (medically treated device infection).	Up to one year post procedure
2. Any treatment with antibiotics for suspected device infection.	Up to one year post procedure
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.	Up to one year post procedure
4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.	Up to one year post procedure
Cost benefit analysis	At completion of data collection period
6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).	Up to one year post procedure

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Andrew Krahn, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): September 8, 2017
• Study Completion (Actual): September 8, 2017

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Infection; Arrhythmia; Antibiotics; Cluster; Device Procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Arrhythmias, Cardiac; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Cefazolin; Cephalexin; Bacitracin
• Other Study ID Numbers: PADIT Cluster Crossover Study