Prevention of Arrhythmia Device Infection Trial (PADIT)

NCT ID: NCT01628666

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12814 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-09-08

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).

Conditions

Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional

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

Group Type: EXPERIMENTAL

Conventional

Intervention Type: DRUG

Cefazolin preoperative

Incremental

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

Group Type: EXPERIMENTAL

Incremental

Intervention Type: DRUG

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

Interventions

Incremental

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

Intervention Type: DRUG

Conventional

Cefazolin preoperative

Intervention Type: DRUG

Other Intervention Names

Cefazolin; Vancomycin; Bacitracin; Cefalexin; Cefazolin

Eligibility Criteria

Inclusion Criteria

1. Age >= 18 years

2. 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)

3. Patient is not known to have device infection at the time of the surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Krahn, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Coordinating Centre: Population Health Research Institute

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

PADIT Cluster Crossover Study

Identifier Type: -

Identifier Source: org_study_id