Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Discontinuation of antibiotics.
- Who it may be relevant to
- Registry conditions: Cardiac Implantable Electronic Device Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Composite endpoint of death or relapse bacteremia [Time frame: 12 months]
Secondary outcome measures (4)
- Death [Time frame: 12 months]
- Readmission for any cause [Time frame: 12 months]
- Device extraction [Time frame: 12 months]
- Change in quality of life [Time frame: 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT05958290 · H-23029723