Comparing lifelong antibiotic therapy to stopping antibiotics for CIED infections
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Capital Region) |
| Trial ID | NCT05958290 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with definite CIED infections who are not eligible for device extraction.
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.
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 performed: While this approach is being tested in this study, similar studies have not been widely reported, indicating a novel exploration in this area.
Eligibility criteria
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 this trial is running
Copenhagen, Capital Region
- Rigshospitalet — Copenhagen, Capital Region, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.