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NCT Number: NCT05958290

Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

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.

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Key information

Conditions

Cardiac Implantable Electronic Device Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location status: Recruiting

Location contact

Emil L Fosbøl

CONTACT

[email protected]

004535456340

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Discontinuation of antibiotics

Other

Discontinuation of antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total.

Primary outcomes

  1. Composite endpoint of death or relapse bacteremia

    Time frame: 12 months

    Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen

Secondary outcomes

  1. 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.

  2. 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.

  3. 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..

  4. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: CIEDLESS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2023
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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