Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study (ABxFREE)
Primary Purpose
Post Procedural Infection, Pacemaker Electrode Infection, Antibiotics
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Antibiotics
Sponsored by
About this trial
This is an interventional prevention trial for Post Procedural Infection focused on measuring Prophylactic antibiotics, Cardiac implantable electronic device infection
Eligibility Criteria
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
Sites / Locations
- National Cheng-Kung University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Post procedural antibiotics treatment
Pre procedural antibiotics treatment only
Arm 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
This group was only treated with pre-procedural (pacemaker or ICD implantation) prophylactic once intravenous antibiotics (cefazolin 1000mg or else if allergy to cefazolin).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04146883
First Posted
October 25, 2019
Last Updated
October 29, 2019
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04146883
Brief Title
Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study
Acronym
ABxFREE
Official Title
Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
August 19, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Procedural Infection, Pacemaker Electrode Infection, Antibiotics, Implantable Defibrillator User
Keywords
Prophylactic antibiotics, Cardiac implantable electronic device infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a multi-center, prospective, randomized and open-labeled study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post procedural antibiotics treatment
Arm Type
Experimental
Arm 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
Arm Title
Pre procedural antibiotics treatment only
Arm Type
No Intervention
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Other Intervention Name(s)
Cephalexin
Intervention Description
Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
Primary Outcome Measure Information:
Title
Cardiac implantable electronic device related infection
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Chen Chiang, Bachelor
Phone
+886-6-2353535
Ext
2388
Email
atiffany543783@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ting-Chun Huang, MD
Phone
+886-6-2353535
Ext
2388
Email
dingean0723@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju-Yi Chen, PhD
Organizational Affiliation
National Cheng-Kung Univerity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Chen Chiang, Bachelor
Phone
+886-6-2353535
Ext
2388
Email
atiffany543783@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share IPD due to the restriction of NCKUH IRB.
Citations:
PubMed Identifier
25355810
Citation
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.
Results Reference
background
PubMed Identifier
28919379
Citation
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. Erratum In: Heart Rhythm. 2021 Oct;18(10):1814.
Results Reference
background
PubMed Identifier
28444977
Citation
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.
Results Reference
result
PubMed Identifier
27122728
Citation
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.
Results Reference
result
PubMed Identifier
30575054
Citation
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.
Results Reference
result
PubMed Identifier
19808441
Citation
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. Erratum In: Circ Arrhythm Electrophysiol. 2009 Feb;2(1):e1. D'Avila, Andre [added].
Results Reference
result
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Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study
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