Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See (CIEDLESS)

Rigshospitalet

Status: Enrolling

Conditions: Cardiac Implantable Electronic Device Infection

Treatments: Other: Discontinuation of antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05958290

H-23029723

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Discontinuation of antibiotics

Experimental group

Treatment:

Other: Discontinuation of antibiotics

Standard treatment

No Intervention group