Comparing device removal with antibiotic treatment for possible heart device infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CIEDOUT study is an open-label randomized trial aimed at evaluating the effectiveness of cardiac implantable electronic device (CIED) removal combined with guideline antibiotic therapy versus a standard 6-week antibiotic therapy alone in patients with suspected CIED infections. The study focuses on patients with bacteremia and possible CIED infection, assessing whether the removal of the device can prevent death or relapse of bacteremia over a 6-month follow-up period. This is the first randomized clinical trial of its kind, addressing a significant gap in current treatment guidelines and practices for managing possible CIED infections.

Why it matters

Who can join: the full rules

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

Where it's running

• Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Emil L Fosbøl, MD, PhD — Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Emil L Fosbøl, MD, PhD
• Email: emil.fosboel@regionh.dk
• Phone: +4535456340

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.