Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
Launched by RIGSHOSPITALET, DENMARK · Jul 14, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether a 6-week course of antibiotics can effectively treat infections related to cardiac implantable electronic devices (like pacemakers) in patients who cannot have their devices removed. The study aims to find out if patients can be successfully treated without needing to remove the device, which can be a complicated procedure.
To be eligible for this trial, participants must have a confirmed infection related to their device and should not be candidates for device removal. If you join the study, you will first receive at least 10 days of intravenous (IV) antibiotics, followed by oral antibiotics for a total of 6 weeks. After finishing the antibiotics, doctors will carefully monitor you to see if the infection comes back. If you choose not to participate, you may still be asked to join a registry to help compare outcomes between those on antibiotics and those who receive standard treatment. This trial is currently recruiting participants of all ages and genders.
Gender
ALL
Eligibility 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)
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, Region Hovedstaden, Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported