Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

Not Applicable

Recruiting

• Conditions: Cardiac Implantable Electronic Device Infection
• Interventions: Other: Discontinuation of antibiotics

• Registration Number: NCT05958290
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Study Start: 2023-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Definite CIED infection by the EHRA criteria
• Deemed non-eligible for CIED extraction

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinuation of antibiotics	Discontinuation of antibiotics	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint of death or relapse bacteremia	12 months	Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen

Secondary Outcome Measures

Name	Time	Method
Death	12 months	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.
Device extraction	12 months	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..
Readmission for any cause	12 months	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.
Change in quality of life	12 months	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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Region Hovedstaden, Denmark