Comparing lifelong antibiotic therapy to stopping antibiotics for CIED infections
Official title: Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
Run by Copenhagen University Hospital, Rigshospitalet · NCT05958290 · Data updated 2026-11-12
This study is testing if a 6-week course of antibiotics can help people with heart device infections who can’t have their device removed, and it will compare their results to those who stop taking antibiotics.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen, Capital Region) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | July 28, 2025 |
| Trial ID | NCT05958290 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with definite CIED infections who are not eligible for device extraction.
✕Probably not a fit
Patients who are unavailable for follow-up or those who do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of a 6-week antibiotic treatment regimen for patients with cardiac implantable electronic device (CIED) infections who cannot undergo device extraction. Participants will receive at least 10 days of intravenous antibiotics followed by oral antibiotics for a total of 6 weeks. After completing the antibiotic course, patients will be monitored for any signs of bacterial relapse. The study also aims to create a registry to compare outcomes of patients who discontinue antibiotics with those receiving standard treatment.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with CIED infections, potentially reducing the need for device extraction.
How similar studies have gone: While this approach is being tested in this study, similar studies have not been widely reported, indicating a novel exploration in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Definite CIED infection by the EHRA criteria * Deemed non-eligible for CIED extraction Exclusion Criteria: * Unavailable for follow-up (e.g., tourist)
Where it's running
-
Rigshospitalet
Copenhagen, Capital Region, Denmark Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing device removal with antibiotic treatment for possible heart device infections
This study is testing whether removing heart devices along with antibiotics can help people with suspected infections do better than just taking antibiotics alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.