Comparing device removal with antibiotic treatment for possible heart device infections

Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment - the CIEDOUT Study - a Randomized Clinical Trial

This study is testing whether removing heart devices along with antibiotics can help people with suspected infections do better than just taking antibiotics alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06323668 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with bacteremia and possible CIED infection, particularly those with specific pathogens detected in blood cultures.

Not a fit: Patients with definite CIED infections or those who are clinically frail may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols that significantly reduce mortality and relapse rates in patients with possible CIED infections.

How similar studies have performed: This study is novel and untested, as no previous randomized clinical trials have been conducted on this specific treatment approach for possible CIED infections.

Eligibility criteria

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 this trial is running

Copenhagen

• 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

Conditions Cardiac Implantable Electronic Device Infection; Cardiac Implantable Electronic Device; CIED; Pacemaker; Implantable cardioverter defibrillator; ICD; Possible CIED infection; Valvular endocarditis