NCT05958290

Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Implantable Electronic Device Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2023-07-24
• Last updated: 2025-07-28

Locations

1 site across 1 country: Denmark