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

National Cheng-Kung University

Status: Unknown

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

Treatments: Drug: Antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04146883

B-ER-108-130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Post procedural antibiotics treatment

Experimental group

Description:

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

Treatment:

Drug: Antibiotics

Pre procedural antibiotics treatment only

No Intervention group

Description:

This group was only treated with pre-procedural (pacemaker or ICD implantation) prophylactic once intravenous antibiotics (cefazolin 1000mg or else if allergy to cefazolin).