Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

Recruiting now · Not applicable

Conditions studied: Cardiac Implantable Electronic Device Infection

In brief

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.

Key facts

Study ID

NCT05958290

Run by

Rigshospitalet, Denmark

People needed

90

Starts

2023-09-01

Expected to finish

2026-11-30

Last updated by the study team

2025-07-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Definite CIED infection by the EHRA criteria
• Deemed non-eligible for CIED extraction

You may not qualify if…

• Unavailable for follow-up (e.g., tourist)

Where it is running

• Rigshospitalet — Copenhagen, Capital Region, Denmark (enrolling)

Full record on ClinicalTrials.gov

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