Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
Launched by RIGSHOSPITALET, DENMARK · Mar 14, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The CIEDOUT study is looking at the best way to treat infections that may be related to cardiac implantable electronic devices (like pacemakers). Researchers want to find out if removing the device and giving patients antibiotic treatment according to guidelines is more effective than just giving antibiotics for six weeks. The goal is to see if this approach can help prevent serious outcomes, like death or a return of the infection, over a six-month period.
To participate in this trial, individuals may be eligible if they have a possible CIED infection and are experiencing a type of bloodstream infection caused by specific germs. Some examples of these germs include Staphylococcus aureus and Enterococcus faecalis. However, patients who definitely have a CIED infection or other severe health issues may not qualify. Those who join the study can expect close monitoring and care throughout the trial, helping to contribute to important research that could improve treatment for future patients facing similar infections.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Possible CIED infection\*
- • AND
- • Bacteremia/fungemia with S. aureus detected in ≥1 positive blood culture(s) or CoNS, Cutibacterium spp., Candida spp, Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis detected in ≥2 positive blood cultures.
- • OR
- • Left-sided valve infective endocarditis
- • AND
- • Possible CIED infection\*
- • AND
- • Bacteremia/fungemia detected in ≥1 positive blood culture(s) with S. aureus, CoNS, Cutibacterium spp., Candida spp., Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis
- Exclusion Criteria:
- • Unavailable for follow-up (e.g. tourist)
- • Unwilling to sign informed consent
- • Unable to sign informed consent
- • OR
- • At least one of the following criteria
- • Not a candidate by clinician discretion
- • Definite CIED infection\*
- • Clinical frailty score ≥7
- • EUROSCORE II \>33%
- • Forced expiratory volume in one second (FEV1) \<1L or \<30% of expected
- • By the modified Duke and ESC diagnostic criteria
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, , Denmark
Patients applied
Trial Officials
Emil L Fosbøl, MD, PhD
Principal Investigator
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported