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

NCT04146883 | Unknown DMC

• 1 other identifier: B-ER-108-130
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prophylactic antibiotics; Cardiac implantable electronic device infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Post procedural antibiotics treatment

EXPERIMENTAL

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

Pre procedural antibiotics treatment only

NO INTERVENTION

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

Interventions

Antibiotics DRUG

Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin

Also known as: Cephalexin

Post procedural antibiotics treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for permanent pacemaker or implantable cardioverter defibrillator implantation according to current guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Related Publications (6)

• Sandoe JA, Barlow G, Chambers JB, Gammage M, Guleri A, Howard P, Olson E, Perry JD, Prendergast BD, Spry MJ, Steeds RP, Tayebjee MH, Watkin R; British Society for Antimicrobial Chemotherapy; British Heart Rhythm Society; British Cardiovascular Society; British Heart Valve Society; British Society for Echocardiography. Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection. Report of a joint Working Party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography (BSE). J Antimicrob Chemother. 2015 Feb;70(2):325-59. doi: 10.1093/jac/dku383. Epub 2014 Oct 29.

  PMID: 25355810 BACKGROUND

• Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.

  PMID: 28919379 BACKGROUND

• Lee WH, Huang TC, Lin LJ, Lee PT, Lin CC, Lee CH, Chao TH, Li YH, Chen JY. Efficacy of postoperative prophylactic antibiotics in reducing permanent pacemaker infections. Clin Cardiol. 2017 Aug;40(8):559-565. doi: 10.1002/clc.22698. Epub 2017 Apr 26.

  PMID: 28444977 RESULT

• Chiang KH, Chao TF, Lee WS, Lin YJ, Tuan TC, Kong CW. How Long Should Prophylactic Antibiotics be Prescribed for Permanent Pacemaker Implantations? One Day versus Three Days. Acta Cardiol Sin. 2013 Jul;29(4):341-6.

  PMID: 27122728 RESULT

• Madadi S, Kafi M, Kheirkhah J, Azhari A, Kiarsi M, Mehryar A, Fazelifar A, Alizadehdiz A, Emkanjoo Z, Haghjoo M. Postoperative antibiotic prophylaxis in the prevention of cardiac implantable electronic device infection. Pacing Clin Electrophysiol. 2019 Feb;42(2):161-165. doi: 10.1111/pace.13592. Epub 2019 Jan 4.

  PMID: 30575054 RESULT

• de Oliveira JC, Martinelli M, Nishioka SA, Varejao T, Uipe D, Pedrosa AA, Costa R, D'Avila A, Danik SB. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):29-34. doi: 10.1161/CIRCEP.108.795906. Epub 2009 Feb 10.

  PMID: 19808441 RESULT

MeSH Terms

Interventions

Anti-Bacterial Agents; Cephalexin

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ju-Yi Chen, PhD

  National Cheng-Kung Univerity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chen Chiang, Bachelor

CONTACT

+886-6-2353535; atiffany543783@gmail.com

Ting-Chun Huang, MD

CONTACT

+886-6-2353535; dingean0723@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Internal Medicine, College of Medicine, National Cheng Kung University

Model Details: This study is a multi-center, prospective, randomized and open-labeled study.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: August 20, 2019
• Primary Completion: August 19, 2020
• Study Completion: December 31, 2021
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)