Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

Study Overview
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Brief Summary
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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.

Official Title
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Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study

Conditions
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Cardiac Implantable Electronic Device Infection

Intervention / Treatment
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* Other: Discontinuation of antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Definite CIED infection by the EHRA criteria Deemed non-eligible for CIED extraction Exclusion Criteria: Unavailable for follow-up (e.g., tourist)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discontinuation of antibiotics<br> | Other: Discontinuation of antibiotics<br>* Discontinuation of antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total.<br>|
| No Intervention: Standard treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of death or relapse bacteremia | Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause mortality. This outcome will be assessed for the main study arm as well as the registry study arm through medical chart review. | 12 months | 
| Readmission for any cause | This outcome will be assessed for the main study arm as well as the registry study arm through medical chart review.. | 12 months | 
| Device extraction | This outcome will be assessed for the main study arm as well as the registry study arm through medical chart review.. | 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. | 12 months |