An interventional study of Antibiotics in Post Procedural Infection, Pacemaker Electrode Infection and Antibiotics, sponsored by National Cheng-Kung University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-10-31.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 800 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
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
This group was only treated with pre-procedural (pacemaker or ICD implantation) prophylactic once intravenous antibiotics (cefazolin 1000mg or else if allergy to cefazolin).
Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
Also known as: Cephalexin
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.
Time frame: 1 year
Plan to share: No — We will not share IPD due to the restriction of NCKUH IRB.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital