Actively Recruiting
Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
Led by Rigshospitalet, Denmark · Updated on 2024-11-20
180
Participants Needed
1
Research Sites
715 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Possible cardiac implantable electronic device (CIED) infection
- Bacteremia or fungemia with Staphylococcus aureus detected in at least 1 positive blood culture or CoNS, Cutibacterium spp., Candida spp., Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis detected in at least 2 positive blood cultures
- Or left-sided valve infective endocarditis
- Possible CIED infection with bacteremia or fungemia detected in at least 1 positive blood culture with the specified microorganisms
You will not qualify if you...
- Unavailable for follow-up (e.g., tourist)
- Unwilling to sign informed consent
- Unable to sign informed consent
- Not a candidate by clinician discretion
- Definite CIED infection
- Clinical frailty score of 7 or higher
- EUROSCORE II greater than 33%
- Forced expiratory volume in one second (FEV1) less than 1 liter or less than 30% of expected
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
E
Emil L Fosbøl, MD, PhD
CONTACT
A
Amna Alhakak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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