Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

Cardiac Implantable Electronic Device Infection Clinical Trial

— CIEDLESS  

Official title:

Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958290
• Other study ID #: H-23029723
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Definite CIED infection by the EHRA criteria

• Deemed non-eligible for CIED extraction

Exclusion Criteria:

• Unavailable for follow-up (e.g., tourist)

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device Infection

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of death or relapse bacteremia	Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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..	12 months
Secondary	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.	12 months