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Prevention of Arrhythmia Device Infection Trial (PADIT)

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: Incremental Drug: Conventional Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12814 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
Actual Study Start Date : December 2012
Actual Primary Completion Date : September 8, 2017
Actual Study Completion Date : September 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization attributed to device infection [ Time Frame: Evaluation is one year post patient's procedure ]

Secondary Outcome Measures :
  1. 1. Proven device infection not requiring surgical intervention (medically treated device infection). [ Time Frame: Up to one year post procedure ]
  2. 2. Any treatment with antibiotics for suspected device infection. [ Time Frame: Up to one year post procedure ]
  3. 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection. [ Time Frame: Up to one year post procedure ]
  4. 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. [ Time Frame: Up to one year post procedure ]
  5. Cost benefit analysis [ Time Frame: At completion of data collection period ]
  6. 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause). [ Time Frame: Up to one year post procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628666


Locations
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Canada, Ontario
Coordinating Centre: Population Health Research Institute
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Andrew Krahn, MD University of British Columbia
More Information
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01628666    
Other Study ID Numbers: PADIT Cluster Crossover Study
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Keywords provided by Population Health Research Institute:
Arrhythmia
Device Procedure
Antibiotics
Infection
Cluster
Additional relevant MeSH terms:
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Infections
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vancomycin
 Cefazolin
Cephalexin
Bacitracin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local