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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

June 4, 2012
June 6, 2012
October 10, 2014
May 2011
November 2013   (Final data collection date for primary outcome measure)
Hospitalization attributed to device infection [ Time Frame: within one year of device procedure ]
Hospitalization attributed to device infection
Not Provided
Complete list of historical versions of study NCT01613092 on ClinicalTrials.gov Archive Site
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Prevention of Arrhythmia Device Infection Trial (PADIT)
Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study
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).
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Arrhythmia
  • Drug: Incremental
    Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
    Other Name: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin
  • Drug: Cefazolin
    Preoperative antibiotic
  • Experimental: Conventional
    Preoperative Antibiotics
    Intervention: Drug: Cefazolin
  • Active Comparator: Aggressive (Incremental)
    Preoperative antibiotics, antibiotic wash and post operative antibiotics
    Intervention: Drug: Incremental
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
Not Provided
December 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01613092
PADIT Cluster Crossover Pilot
Yes
Not Provided
Not Provided
Population Health Research Institute
Population Health Research Institute
Not Provided
Principal Investigator: Dr. Andrew Krahn, M.D University of British Columbia
Population Health Research Institute
October 2014

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