Actively Recruiting
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
Led by Rigshospitalet, Denmark · Updated on 2025-07-28
90
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this non-randomized prospective study is to test whether 6-weeks antibiotic treatment can cure an cardiac implantable electronic device (CIED) infection in patients where device extraction is not feasible. The main question it aims to answer: • Is 6-weeks medical therapy effective in curing definite CIED infection with device retention? Participants will discontinue the antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. After discontinuation of antibiotics, patients are closely observed for bacterial relapse. For patients who are not interested in participation and who do not have exclusion criteria, we will ask for consent into a registry as we wish to compare patients undergoing discontinuation of antibiotics with patients undergoing standard treatment.
CONDITIONS
Official Title
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Definite CIED infection by the EHRA criteria
- Deemed non-eligible for CIED extraction
You will not qualify if you...
- Unavailable for follow-up (e.g., tourist)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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