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Prevention of Arrhythmia Device Infection Trial (PADIT)

This study is currently recruiting participants.
Verified May 2013 by Population Health Research Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01628666
First received: June 4, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce infection 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
Arrhythmia
 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:

U.S. FDA Resources

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: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional
Preoperative Antibiotics
 Drug: Conventional
Cefazolin preoperative
Other Name: Cefazolin
Experimental: Incremental
Preoperative antibiotics, antibiotic wash and post operative antibiotics
 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. 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.

  Eligibility

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

Inclusion Criteria:

  1. Age >= 18 years

  2. Received one of the following procedures:

    a) 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) b) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628666

Contacts
Contact: Kim Simek 905-527-4322 ext 40524

Locations
Canada, Ontario
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)
Investigators
Principal Investigator: Andrew Krahn, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01628666     History of Changes
Other Study ID Numbers: PADIT Cluster Crossover Study
Study First Received: June 4, 2012
Last Updated: May 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by Population Health Research Institute:
Arrhythmia
Device Procedure
Antibiotics
Infection
Cluster

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Bacterial Agents
Bacitracin
Cefazolin
 Cephalexin
Vancomycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on May 19, 2013