- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146883
Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study (ABxFREE)
October 29, 2019 updated by: Ju-Yi Chen, National Cheng-Kung University Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui-Chen Chiang, Bachelor
- Phone Number: 2388 +886-6-2353535
- Email: atiffany543783@gmail.com
Study Contact Backup
- Name: Ting-Chun Huang, MD
- Phone Number: 2388 +886-6-2353535
- Email: dingean0723@gmail.com
Study Locations
-
-
-
Tainan, Taiwan, 704
- Recruiting
- National Cheng-Kung University Hospital
-
Contact:
- Hui-Chen Chiang, Bachelor
- Phone Number: 2388 +886-6-2353535
- Email: atiffany543783@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
Other Names:
|
No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac implantable electronic device related infection
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ju-Yi Chen, PhD, National Cheng-Kung Univerity Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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].
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2019
Primary Completion (Anticipated)
August 19, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 25, 2019
First Submitted That Met QC Criteria
October 29, 2019
First Posted (Actual)
October 31, 2019
Study Record Updates
Last Update Posted (Actual)
October 31, 2019
Last Update Submitted That Met QC Criteria
October 29, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-ER-108-130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We will not share IPD due to the restriction of NCKUH IRB.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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