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

Not Applicable

• Conditions: Pacemaker Electrode Infection; Post Procedural Infection; Antibiotics; Implantable Defibrillator User
• Interventions: Drug: Antibiotics

• Registration Number: NCT04146883
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-20
• Status Verified: 2019-10
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31
• Primary Completion: 2020-08-19
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post procedural antibiotics treatment	Antibiotics	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

Primary Outcome Measures

Name	Time	Method
Cardiac implantable electronic device related infection	1 year	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.

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan