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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Discontinuation of antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total.
Rigshospitalet
Copenhagen, Capital Region, Denmark
RECRUITINGComposite endpoint of death or relapse bacteremia
Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen
Time frame: 12 months
Death
All-cause mortality. The number of patients who die within 12 months will be assessed for the main study arm as well as the registry study arm through medical chart review.
Time frame: 12 months
Readmission for any cause
The number of patients readmitted for any cause will be examined for the main study arm as well as the registry study arm through medical chart review.
Time frame: 12 months
Device extraction
The number of patients who have their device extracted will be assessed for the main study arm as well as the registry study arm through medical chart review..
Time frame: 12 months
Change in quality of life
Quality of life will be assessed at inclusion and after 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ) evaluated with a face-to-face interview. We will evaluate changes in KCCQ scores from inclusion to end of follow-up. This outcome will only be assessed for the main study arm.
Time frame: 12 months
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