Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

Study Overview
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Brief Summary
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The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk patients undergoing arrhythmia device procedures. All antibiotics are approved for use and readily available.

Detailed Description
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Infection can occur after surgery for either a pacemaker or an implantable defibrillation and can have very serious consequences. These infections are common and can be seen in as many as 2-3% of high-risk patients. Doctors use antibiotics to prevent these infections, but we do not know how much or how often to give the antibiotics to get the best effect. It is not known whether additional antibiotics during and after the operation would further reduce the risk of infection. This research study will compare two different ways of using common antibiotics to prevent infection during and following a device procedure. One way is the standard approach of a single dose before surgery and the other way uses more antibiotics. We do not know if either way is better. The purpose of this study therefore, is to compare two types of antibiotic therapy plans to better understand if one is most effective in preventing infection. This study will provide the ability to evaluate the feasibility (i.e. site activation, enrollment, compliance, drop-out) and generate proof of concept for the larger clinical trial of 12,000 patients in all 25 Canadian Hospitals implanting ICDs, which will be submitted to the CIHR. Additionally, the study supports the continued initiatives of the network of physician investigators (Canadian Heart Rhythm Society Device Advisory Committee - CHRS DAC) collaborating to address arrhythmia procedures related clinical trials that will answer simple clinical questions that will focus initially on safety issues.

Official Title
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Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection

Conditions
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Arrythmias

Intervention / Treatment
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* Drug: Cefazolin, Bacitracin, Cefalexin
* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years One of the following planned device procedures: ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement or Pocket or lead revision or System upgrade (insertion or attempted insertion of leads) or New cardiac resynchronization therapy device implant (pacemaker or ICD) Exclusion Criteria: Unable or unwilling to provide written informed consent Unable or unwilling to complete the study follow-up schedule Life expectancy < 12 months as per the opinion if the local investigator Allergy to or unable to tolerate cefazolin or clindamycin or vancomycin Allergy to or unable to tolerate intracavitary bacitracin or gentamicin or cefazolin Previously enrolled in this trial In another study that would confound the results of this trial

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aggressive Antibiotic therapy<br>Patients receive preoperative intravenous antibiotics, intracavitary antibiotics during surgery and postoperative antibiotics. | Drug: Cefazolin, Bacitracin, Cefalexin<br>* Single does of Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision, Bacitracin wash, Cefalexin 250-500 mg TID<br>|
| Active Comparator: Conventional Antibiotic Therapy<br>Preoperative intravenous antibiotics | Drug: Cefazolin<br>* Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization attributed to device infection. |  | Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Any treatment with antibiotics for suspected device infection. |  | Patients will have one follow-up visit at 12 months | 
| 2. Antibiotic therapy related adverse event. |  | Patients will have one follow-up visit at 12 months | 
| 3. Prolongation of hospitalization due to proven or suspected adverse events from the hospitalization. |  | Patients will have one follow-up visit at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Device procedure, pacemaker, ICD, antibiotics