Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

Condition(s) studied

Investigational drug(s) / intervention(s)

Discontinuation 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Composite endpoint of death or relapse bacteremia — 12 months
  Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen

Trial sites (1)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

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