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Prevention of Arrhythmia Device Infection Trial (PADIT)

Primary Purpose

Arrhythmia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Incremental
Cefazolin
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia focused on measuring Arrhythmia, Device Procedure, High risk patients, Antibiotics, Infection, Cluster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hamilton General Hospital, McMaster University
  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional

Aggressive (Incremental)

Arm Description

Preoperative Antibiotics

Preoperative antibiotics, antibiotic wash and post operative antibiotics

Outcomes

Primary Outcome Measures

Hospitalization attributed to device infection
Hospitalization attributed to device infection

Secondary Outcome Measures

Full Information

First Posted
June 4, 2012
Last Updated
October 9, 2014
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01613092
Brief Title
Prevention of Arrhythmia Device Infection Trial (PADIT)
Official Title
Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Arrhythmia, Device Procedure, High risk patients, Antibiotics, Infection, Cluster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Experimental
Arm Description
Preoperative Antibiotics
Arm Title
Aggressive (Incremental)
Arm Type
Active Comparator
Arm Description
Preoperative antibiotics, antibiotic wash and post operative antibiotics
Intervention Type
Drug
Intervention Name(s)
Incremental
Other Intervention Name(s)
Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin
Intervention Description
Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
Preoperative antibiotic
Primary Outcome Measure Information:
Title
Hospitalization attributed to device infection
Description
Hospitalization attributed to device infection
Time Frame
within one year of device procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: > 18 years received one of the following procedures: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Andrew Krahn, M.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital, McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

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Prevention of Arrhythmia Device Infection Trial (PADIT)

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