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Prevention of Arrhythmia Device Infection Trial (PADIT)

This study is ongoing, but not recruiting participants.
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: September 26, 2016
Last verified: September 2016

June 4, 2012
September 26, 2016
December 2012
September 2017   (Final data collection date for primary outcome measure)
Hospitalization attributed to device infection [ Time Frame: Evaluation is one year post patient's procedure ]
Same as current
Complete list of historical versions of study NCT01628666 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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).

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Arrhythmia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12814
January 2018
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01628666
PADIT Cluster Crossover Study
Yes
Not Provided
Not Provided
Not Provided
Population Health Research Institute
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Andrew Krahn, MD University of British Columbia
Population Health Research Institute
September 2016

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