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Prevention of Arrhythmia Device Infection Trial (PADIT)

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ClinicalTrials.gov Identifier: NCT01613092
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
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).

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

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  (Clinical Trial)
Actual Enrollment : 241 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 Pilot Study
Study Start Date : May 2011
Primary Completion Date : November 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin



Primary Outcome Measures :
  1. Hospitalization attributed to device infection [ Time Frame: within one year of device procedure ]
    Hospitalization attributed to device infection



Information from the National Library of Medicine

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

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.

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): NCT01613092


Locations
Canada, Ontario
Hamilton General Hospital, McMaster University
Hamilton, Ontario, Canada, L8L 2X2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Dr. Andrew Krahn, M.D University of British Columbia

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01613092     History of Changes
Other Study ID Numbers: PADIT Cluster Crossover Pilot
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: October 10, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Infection
Anti-Bacterial Agents
Vancomycin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cefazolin
Cephalexin
Bacitracin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local