NCT06323668 Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
| NCT ID | NCT06323668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Cardiac Implantable Electronic Device Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-05-17 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Emil L Fosbøl, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Frequently Asked Questions
Who can join the NCT06323668 clinical trial?
This trial is open to participants of all sexes, studying Cardiac Implantable Electronic Device Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06323668 currently recruiting?
Yes, NCT06323668 is actively recruiting participants. Contact the research team at emil.fosboel@regionh.dk for enrollment information.
Where is the NCT06323668 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06323668 clinical trial?
NCT06323668 is sponsored by Rigshospitalet, Denmark. The principal investigator is Emil L Fosbøl, MD, PhD at Department of Cardiology, Copenhagen University Hospital, Rigshospitalet. The trial plans to enroll 180 participants.