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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05958290
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Implantable Electronic Device Infection	Other: Discontinuation of antibiotics	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2025
• Anticipated Study Completion Date: Nov 30, 2025

Arms and Interventions

Arm	Intervention/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.
No Intervention: Standard treatment

Outcome Measures

Primary Outcome Measures

1. 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

1. Death [12 months]

   All-cause mortality. This outcome will be assessed for the main study arm as well as the registry study arm through medical chart review.

2. Readmission for any cause [12 months]

   This outcome will be assessed for the main study arm as well as the registry study arm through medical chart review..

3. Device extraction [12 months]

   This outcome 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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Definite CIED infection by the EHRA criteria

• Deemed non-eligible for CIED extraction

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen	Region Hovedstaden	Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emil Loldrup Fosbol, Professor, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT05958290
• Other Study ID Numbers: H-23029723
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 25, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anti-Bacterial Agents

Study Results

No Results Posted as of Jul 25, 2023