Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See (CIEDLESS)

April 9, 2024 updated by: Emil Loldrup Fosbol, Rigshospitalet, Denmark

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:

• 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard treatment
Experimental: Discontinuation of antibiotics
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of death or relapse bacteremia
Time Frame: 12 months
Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: 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.
12 months
Death
Time Frame: 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.
12 months
Readmission for any cause
Time Frame: 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.
12 months
Device extraction
Time Frame: 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..
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23029723

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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