Prevention of Arrhythmia Device Infection Trial (PADIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01613092
First received: June 4, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Arrhythmia
Drug: Incremental
Drug: Cefazolin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Hospitalization attributed to device infection [ Time Frame: within one year of device procedure ] [ Designated as safety issue: No ]
    Hospitalization attributed to device infection


Enrollment: 241
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01613092     History of Changes
Other Study ID Numbers: PADIT Cluster Crossover Pilot
Study First Received: June 4, 2012
Last Updated: October 9, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cefazolin
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014