Cardiac Implantable Electronic Device Infection
Conditions
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.
Interventions
OTHERDiscontinuation of antibiotics
Discontinuation of antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Definite CIED infection by the EHRA criteria * Deemed non-eligible for CIED extraction
Exclusion criteria
* Unavailable for follow-up (e.g., tourist)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of death or relapse bacteremia | 12 months | Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 12 months | 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. |
| Readmission for any cause | 12 months | 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. |
| Device extraction | 12 months | 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.. |
| Change in quality of life | 12 months | 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. |
Countries
Denmark
Outcome results
None listed