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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

Conventional

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Age >= 18 years
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)
Patient is not known to have device infection at the time of the surgery

Sites / Locations

Coordinating Centre: Population Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Conventional

Incremental

Arm Description

Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.

Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.

Outcomes

Primary Outcome Measures

Hospitalization attributed to device infection

Secondary Outcome Measures

1. Proven device infection not requiring surgical intervention (medically treated device infection).

2. Any treatment with antibiotics for suspected device infection.

3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.

4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.

Cost benefit analysis

6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).

Full Information

NCT ID

NCT01628666

First Posted

June 4, 2012

Last Updated

June 20, 2019

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT01628666

Brief Title

Prevention of Arrhythmia Device Infection Trial (PADIT)

Official Title

Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

December 2012 (Actual)

Primary Completion Date

September 8, 2017 (Actual)

Study Completion Date

September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrhythmia

Keywords

Arrhythmia, Device Procedure, 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

12814 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional

Arm Type

Experimental

Arm Description

Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.

Arm Title

Incremental

Arm Type

Experimental

Arm Description

Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.

Intervention Type

Drug

Intervention Name(s)

Incremental

Other Intervention Name(s)

Cefazolin, Vancomycin, Bacitracin, Cefalexin

Intervention Description

Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.

Intervention Type

Drug

Intervention Name(s)

Conventional

Other Intervention Name(s)

Cefazolin

Intervention Description

Cefazolin preoperative

Primary Outcome Measure Information:

Title

Hospitalization attributed to device infection

Time Frame

Evaluation is one year post patient's procedure

Secondary Outcome Measure Information:

Title

1. Proven device infection not requiring surgical intervention (medically treated device infection).

Time Frame

Up to one year post procedure

Title

2. Any treatment with antibiotics for suspected device infection.

Time Frame

Up to one year post procedure

Title

3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.

Time Frame

Up to one year post procedure

Title

4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.

Time Frame

Up to one year post procedure

Title

Cost benefit analysis

Time Frame

At completion of data collection period

Title

6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).

Time Frame

Up to one year post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >= 18 years Received one of the following procedures: A second or subsequent procedure on the arrhythmia device pocket: ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement Pocket or lead revision System upgrade (insertion or attempted insertion of leads) New cardiac resynchronization therapy device implant (pacemaker or ICD) Patient is not known to have device infection at the time of the surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Krahn, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Coordinating Centre: Population Health Research Institute

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

12. IPD Sharing Statement

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Prevention of Arrhythmia Device Infection Trial (PADIT)

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