Post Procedural InfectionABxFREENCT04146883
Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study
A study testing Antibiotics in people with Post Procedural Infection and Pacemaker Electrode Infection, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post Procedural Infection, Pacemaker Electrode Infection, Antibiotics
- What is being tested?
- Antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for permanent pacemaker or implantable cardioverter defibrillator implantation according to current guidelines
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Hui-Chen Chiang, Bachelor, +886-6-2353535 ext. 2388, atiffany543783@gmail.com
About this study
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.
Read the 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.
- Conditions
- Post Procedural Infection, Pacemaker Electrode Infection, Antibiotics, Implantable Defibrillator User
- Being tested
- Antibiotics
- Keywords
- Prophylactic antibiotics, Cardiac implantable electronic device infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Also called Cephalexin
Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start20 Aug 2019
- Primary completion19 Aug 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Procedural InfectionStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multi-center, prospective, randomized and open-labeled study.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju-Yi Chen, National Cheng-Kung University Hospital
- Investigators
- Ju-Yi Chen, PhD, Principal investigator, National Cheng-Kung Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146883
- Sponsor's protocol ID
- B-ER-108-130
- Acronym
- ABxFREE
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD due to the restriction of NCKUH IRB.
Publications
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.
PubMed 25355810Kusumoto 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.
PubMed 28919379Lee 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.
PubMed 28444977Chiang 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.
PubMed 27122728Madadi 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.
PubMed 30575054de 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.
PubMed 19808441
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study
- ClinicalTrials.gov ID
- NCT04146883
- Acronym / sponsor ID
- ABxFREE / B-ER-108-130
- Conditions
- Post Procedural Infection, Pacemaker Electrode Infection, Antibiotics, Implantable Defibrillator User
- Keywords
- Prophylactic antibiotics, Cardiac implantable electronic device infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 19 Aug 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a multi-center, prospective, randomized and open-labeled study.
| Arm | Type | Receives |
|---|---|---|
| Post procedural antibiotics treatment | Experimental | Drug: AntibioticsThis 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 |
| 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for permanent pacemaker or implantable cardioverter defibrillator implantation according to current guidelines
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAlso: CephalexinPost-procedural one-day iv cefazolin then 3-day prophylactic cephalexin | Drug | Post procedural antibiotics treatment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Background: PubMed 25355810Sandoe 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.
- Background: PubMed 28919379Kusumoto 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.
- Results publication: PubMed 28444977Lee 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 publication: PubMed 27122728Chiang 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 publication: PubMed 30575054Madadi 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 publication: PubMed 19808441de 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.
- Individual participant dataSharing planned: No. We will not share IPD due to the restriction of NCKUH IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Yi Chen, PhD principal investigator
National Cheng-Kung Univerity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotics in people with Post Procedural Infection and Pacemaker Electrode Infection, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Chen Chiang, Bachelor (+886-6-2353535 ext. 2388, atiffany543783@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac implantable electronic device related infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146883, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.