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Clinical Trials in Denmark / NCT06323668
Recruiting Not applicable

Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment

NCT06323668 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2024-05-17
Last updated
2024-11-20

Condition(s) studied

Cardiac Implantable Electronic Device Infection

Investigational drug(s) / intervention(s)

Cardiac implantable electronic device extraction

Cardiac implantable electronic device extraction: The CIED removal will be done as soon as possible within 7 days.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of death or relapse bacteremia — 6 months after randomization
    Composite endpoint of death or relapse bacteremia (same microorganism)

Trial sites (1)

FacilityCityRegionStatus
Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06323668 on ClinicalTrials.gov ↗ ← All trials in Denmark