Prevention of Arrhythmia Device Infection Trial (PADIT)

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

The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).

Study Overview

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

Detailed Description

Multi-center, cluster crossover, unblinded, pilot study. Centers will be randomized to conventional vs. incremental antibiotic therapy for 2 months or until eligible 20 patients are treated, whichever comes first. At 2 months, centers will have a crossover period of 4 weeks where the alternate strategy is implemented, followed by the final 2-month/20 patient enrolment period. During each treatment period the randomized antibiotic strategy will be used on all center patients undergoing a device implant procedure. Prior to the planned surgery or at the first follow up visit, patients who meet the study eligibility criteria will be approached to obtain consent for data collection purposes. Follow up will be according to usual clinical care at the center.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital, McMaster University
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart 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:

• > 18 years

• received one of the following procedures:

  1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)
  2. new cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion Criteria:

• life expectancy < 12 months in the opinion of the local investigator.
• allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
• allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
• pre-operative identification that the patient has infection.

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	Drug: Cefazolin; Preoperative antibiotic
Active Comparator: Aggressive (Incremental); Preoperative antibiotics, antibiotic wash and post operative antibiotics	Drug: Incremental; Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin; Other Names: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization attributed to device infection	Hospitalization attributed to device infection	within one year of device procedure

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Dr. Andrew Krahn, M.D, University of British Columbia

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 6, 2012

Study Record Updates

• Last Update Posted (Estimate): October 10, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Infection; Arrhythmia; Antibiotics; Cluster; High risk patients; Device Procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Arrhythmias, Cardiac; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Clindamycin; Cefazolin; Cephalexin; Bacitracin
• Other Study ID Numbers: PADIT Cluster Crossover Pilot