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Prevention of Arrhythmia Device Infection Trial (PADIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01628666
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Population Health Research Institute

Tracking Information
First Submitted Date  ICMJE June 4, 2012
First Posted Date  ICMJE June 27, 2012
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE December 2012
Actual Primary Completion Date September 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
Hospitalization attributed to device infection [ Time Frame: Evaluation is one year post patient's procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
  • 1. Proven device infection not requiring surgical intervention (medically treated device infection). [ Time Frame: Up to one year post procedure ]
  • 2. Any treatment with antibiotics for suspected device infection. [ Time Frame: Up to one year post procedure ]
  • 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection. [ Time Frame: Up to one year post procedure ]
  • 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. [ Time Frame: Up to one year post procedure ]
  • Cost benefit analysis [ Time Frame: At completion of data collection period ]
  • 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause). [ Time Frame: Up to one year post procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Arrhythmia Device Infection Trial (PADIT)
Official Title  ICMJE Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Arrhythmia
Intervention  ICMJE
  • Drug: Incremental
    Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
    Other Names:
    • Cefazolin
    • Vancomycin
    • Bacitracin
    • Cefalexin
  • Drug: Conventional
    Cefazolin preoperative
    Other Name: Cefazolin
Study Arms  ICMJE
  • Experimental: Conventional
    Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
    Intervention: Drug: Conventional
  • Experimental: Incremental
    Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
    Intervention: Drug: Incremental
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
12814
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2012)
10800
Actual Study Completion Date  ICMJE September 8, 2017
Actual Primary Completion Date September 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01628666
Other Study ID Numbers  ICMJE PADIT Cluster Crossover Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Andrew Krahn, MD University of British Columbia
PRS Account Population Health Research Institute
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP