RecruitingNot Applicable

Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment

Denmark180 participantsStarted 2024-05-17

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of death or relapse bacteremia

Timeframe: 6 months after randomization

Trial details

NCT IDNCT06323668

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Emil L Fosbøl, MD, PhD

+4535456340 emil.fosboel@regionh.dk

View on ClinicalTrials.gov More Cardiac Implantable Electronic Device Infection trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.