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

NCT ID: NCT04146883

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2021-12-31

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.

Conditions

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Post Procedural Infection Pacemaker Electrode Infection Antibiotics Implantable Defibrillator User

Keywords

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Prophylactic antibiotics Cardiac implantable electronic device infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a multi-center, prospective, randomized and open-labeled study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Post procedural antibiotics treatment

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

Group Type EXPERIMENTAL

Antibiotics

Intervention Type DRUG

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

Pre procedural antibiotics treatment only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antibiotics

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

Intervention Type DRUG

Other Intervention Names

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Cephalexin

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju-Yi Chen

Associate Professor, Department of Internal Medicine, College of Medicine, National Cheng Kung University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ju-Yi Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung Univerity Hospital

Locations

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National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hui-Chen Chiang, Bachelor

Role: CONTACT

Phone: +886-6-2353535

Email: [email protected]

Ting-Chun Huang, MD

Role: CONTACT

Phone: +886-6-2353535

Email: [email protected]

Facility Contacts

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Hui-Chen Chiang, Bachelor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25355810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28919379 (View on PubMed)

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.

Reference Type RESULT
PMID: 28444977 (View on PubMed)

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.

Reference Type RESULT
PMID: 27122728 (View on PubMed)

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.

Reference Type RESULT
PMID: 30575054 (View on PubMed)

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.

Reference Type RESULT
PMID: 19808441 (View on PubMed)

Other Identifiers

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B-ER-108-130

Identifier Type: -

Identifier Source: org_study_id