Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study

Study Overview
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Brief Summary
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This study is a multi-center open-label randomized study, and we sought to investigate the redundancy of post-procedural prophylactic antibiotics in cardiac implantable electronic device implantation. There are 2 arms in this study. One arm will receive pre-procedural intravenous antibiotics only. The other arm will receive both pre-procedural intravenous antibiotics and post-procedural 3-day oral antibiotics.

Detailed Description
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There is general agreement on the benefits of preoperative prophylactic antibiotics which had been documented in previous studies. Concerns of bacterial resistance and unnecessary cost, our prospective observational case-control study had suggested the redundancy of post-procedural antibiotics. In this well-designed study, we sought to investigate the efficacy of post-procedural antibiotics and confirm the hypothesis.

Official Title
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Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study

Conditions
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Post Procedural Infection, Pacemaker Electrode Infection, Antibiotics, Implantable Defibrillator User

Intervention / Treatment
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* Drug: Antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for permanent pacemaker or implantable cardioverter defibrillator implantation according to current guidelines Exclusion Criteria: Hospitalization for more than 7 days End stage renal disease with hemodialysis or peritonealysis Patients receive cardiac resynchronization therapy, His-bundle pacemaker, leadless pacemaker, or sub-cutaneous implantable cardioverter defibrillator

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: This study is a multi-center, prospective, randomized and open-labeled study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post procedural antibiotics treatment<br>This group was treated with pre-procedural (pacemaker or ICD implantation) prophylactic once intravenous antibiotics (cefazolin 1000mg or else if allergy to cefazolin) and post procedural oral prophylactic antibiotics | Drug: Antibiotics<br>* Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin<br>* Other names: Cephalexin;|
| No Intervention: Pre procedural antibiotics treatment only<br>This group was only treated with pre-procedural (pacemaker or ICD implantation) prophylactic once intravenous antibiotics (cefazolin 1000mg or else if allergy to cefazolin). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac implantable electronic device related infection | Any local and systemic signs/symptoms (pocket erosion, localized pocket erythema, swelling, heatness, pain, fever, bacteremia, lead/valvular vegetation) will be monitored during follow-up. The definition and classification of CIED related infection are based on the current guideline and expert consensus statement. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylactic antibiotics, Cardiac implantable electronic device infection