Prevention of Arrhythmia Device Infection Trial (PADIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Population Health Research Institute Identifier:
First received: June 4, 2012
Last updated: November 16, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Drug: Incremental
Drug: Conventional
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study

Resource links provided by NLM:

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Hospitalization attributed to device infection [ Time Frame: Evaluation is one year post patient's procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Proven device infection not requiring surgical intervention (medically treated device infection). [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
  • 2. Any treatment with antibiotics for suspected device infection. [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
  • 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection. [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
  • 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
  • Cost benefit analysis [ Time Frame: At completion of data collection period ] [ Designated as safety issue: No ]
  • 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause). [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 10800
Study Start Date: December 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional
Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
Drug: Conventional
Cefazolin preoperative
Other Name: 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

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).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01628666

Contact: Kim Simek 905-527-4322 ext 40524

Canada, Ontario
Coordinating Centre: Population Health Research Institute Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Carlos Morillo         
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Andrew Krahn, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Population Health Research Institute Identifier: NCT01628666     History of Changes
Other Study ID Numbers: PADIT Cluster Crossover Study 
Study First Received: June 4, 2012
Last Updated: November 16, 2015
Health Authority: Canada: Health Canada

Keywords provided by Population Health Research Institute:
Device Procedure

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses processed this record on February 09, 2016