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Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment

RecruitingNAAges any - anyAllCopenhagen University Hospital, Rigshospitalet
NCT06323668 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection. The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection). The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection.

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📋 Eligibility rules (as published)
Inclusion Criteria: Possible CIED infection\* AND Bacteremia/fungemia with S. aureus detected in ≥1 positive blood culture(s) or CoNS, Cutibacterium spp., Candida spp, Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis detected in ≥2 positive blood cultures. OR Left-sided valve infective endocarditis AND Possible CIED infection\* AND Bacteremia/fungemia detected in ≥1 positive blood culture(s) with S. aureus, CoNS, Cutibacterium spp., Candida spp., Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis Exclusion Criteria: * Unavailable for follow-up (e.g. tourist) * Unwilling to sign informed consent * Unable to sign informed consent OR At least one of the following criteria * Not a candidate by clinician discretion * Definite CIED infection\* * Clinical frailty score ≥7 * EUROSCORE II \>33% * Forced expiratory volume in one second (FEV1) \<1L or \<30% of expected * By the modified Duke and ESC diagnostic criteria
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What it tests

  • Cardiac implantable electronic device extraction
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Where

1 site
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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