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RECRUITING
NCT05958290
NA

Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-09-01

Completion Date

2026-11-30

Last Updated

2025-07-28

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

Rigshospitalet

Copenhagen, Capital Region, Denmark