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Compares treatment options for Cardiac Implantable Electronic Device Infection
Official title Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
ClinicalTrials.gov ID: NCT06323668
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Possible CIED infection\
- Bacteremia/fungemia with S. aureus detected in ≥1 positive blood culture(s) or CoNS, Cutibacterium spp., Candida spp, Streptococcus spp. (except...
- Left-sided valve infective endocarditis
- Possible CIED infection\
- Bacteremia/fungemia detected in ≥1 positive blood culture(s) with S. aureus, CoNS, Cutibacterium spp., Candida spp., Streptococcus spp. (except...
You likely can't join 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
See the full eligibility criteria
- Possible CIED infection\
- 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...
- Left-sided valve infective endocarditis
- Possible CIED infection\
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.