Prevention of Arrhythmia Device Infection Trial (PADIT)

Phase 4

Completed

• Conditions: Arrhythmia
• Interventions: Drug: Conventional; Drug: Incremental

• Registration Number: NCT01628666
• Lead Sponsor: Population Health Research Institute

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).

Study Timeline

• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Study Start: 2012-12
• Primary Completion: 2017-09-08
• Study Completion: 2017-09-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12814

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional	Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
Incremental	Incremental	Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.

Primary Outcome Measures

Name	Time	Method
Hospitalization attributed to device infection	Evaluation is one year post patient's procedure

Secondary Outcome Measures

Name	Time	Method
1. Proven device infection not requiring surgical intervention (medically treated device infection).	Up to one year post procedure
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.	Up to one year post procedure
4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.	Up to one year post procedure
Cost benefit analysis	At completion of data collection period
2. Any treatment with antibiotics for suspected device infection.	Up to one year post procedure
6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).	Up to one year post procedure

Trial Locations

Locations (1)

Coordinating Centre: Population Health Research Institute; 🇨🇦 Hamilton, Ontario, Canada