Cardiac Implantable Electronic Device InfectionCIEDLESSNCT05958290
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
A study testing Discontinuation of antibiotics in people with Cardiac Implantable Electronic Device Infection, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Implantable Electronic Device Infection
- What is being tested?
- Discontinuation of antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Definite CIED infection by the EHRA criteria
- Deemed non-eligible for CIED extraction
Who cannot join
- Unavailable for follow-up (e.g., tourist)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Capital Region, 2100
Emil L Fosbøl, 004535456340, emil.fosboel@regionh.dk
About this study
Official title: Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
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:
Read more
- 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.
- Being tested
- Discontinuation of antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of antibioticsOther
Discontinuation of antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total.
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation of antibiotics | Experimental | Not described Receives: Other: Discontinuation of antibiotics |
| Standard treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of death or relapse bacteremia
Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen
Measured: 12 months
Secondary outcomes (4)
Death
All-cause mortality. The number of patients who die within 12 months will be assessed for the main study arm as well as the registry study arm through medical chart review.
Measured: 12 months
Readmission for any cause
The number of patients readmitted for any cause will be examined for the main study arm as well as the registry study arm through medical chart review.
Measured: 12 months
Device extraction
The number of patients who have their device extracted will be assessed for the main study arm as well as the registry study arm through medical chart review..
Measured: 12 months
Change in quality of life
Quality of life will be assessed at inclusion and after 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ) evaluated with a face-to-face interview. We will evaluate changes in KCCQ scores from inclusion to end of follow-up. This outcome will only be assessed for the main study arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Implantable Electronic Device InfectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Loldrup Fosbol, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958290
- Sponsor's protocol ID
- H-23029723
- Acronym
- CIEDLESS
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
- ClinicalTrials.gov ID
- NCT05958290
- Acronym / sponsor ID
- CIEDLESS / H-23029723
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of antibiotics | Experimental | Other: Discontinuation of antibiotics |
| Standard treatment | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Definite CIED infection by the EHRA criteria
- Deemed non-eligible for CIED extraction
Key exclusion criteria (1 listed)
- Unavailable for follow-up (e.g., tourist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of antibioticsDiscontinuation of antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. | Other | Discontinuation of antibiotics |
Primary outcome
Composite endpoint of death or relapse bacteremia
Time frame: 12 months
Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of antibiotics in people with Cardiac Implantable Electronic Device Infection, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of death or relapse bacteremia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.