Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
Recruiting now · Not applicable
Conditions studied: Cardiac Implantable Electronic Device Infection
In brief
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.
Key facts
- Study ID
- NCT06323668
- Run by
- Rigshospitalet, Denmark
- People needed
- 180
- Starts
- 2024-05-17
- Expected to finish
- 2038-01-31
- Last updated by the study team
- 2024-11-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (enrolling)
Full record on ClinicalTrials.gov
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