Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Implantable Electronic Device Infection
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Composite endpoint of death or relapse bacteremia
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Emil Loldrup Fosbol
Professor
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Definite CIED infection by the EHRA criteria
- •Deemed non-eligible for CIED extraction
Exclusion Criteria
- •Unavailable for follow-up (e.g., tourist)
Outcomes
Primary Outcomes
Composite endpoint of death or relapse bacteremia
Time Frame: 12 months
Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen
Secondary Outcomes
- Death(12 months)
- Device extraction(12 months)
- Readmission for any cause(12 months)
- Change in quality of life(12 months)