Prevention of Arrhythmia Device Infection Trial (PADIT)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arrhythmia

Intervention / Treatment
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* Drug: Incremental
* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional<br>Preoperative Antibiotics | Drug: Cefazolin<br>* Preoperative antibiotic<br>|
| Active Comparator: Aggressive (Incremental)<br>Preoperative antibiotics, antibiotic wash and post operative antibiotics | Drug: Incremental<br>* Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin<br>* Other names: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization attributed to device infection | Hospitalization attributed to device infection | within one year of device procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrhythmia, Device Procedure, High risk patients, Antibiotics, Infection, Cluster