Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment

NCT06323668 | Recruiting DMC

• 1 other identifier: H-23067693
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection. The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection). The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection.

Conditions

Cardiac Implantable Electronic Device Infection

Keywords

Cardiac Implantable Electronic Device; CIED; Pacemaker; Implantable cardioverter defibrillator; ICD; Possible CIED infection; Valvular endocarditis; Bacteremia; CIED extraction; Antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• Rate of death or relapse bacteremia

  Composite endpoint of death or relapse bacteremia (same microorganism)

  6 months after randomization

Secondary Outcomes (7)

• Days alive and out-of-hospital

  6 months after randomization

• Rate of death

  6 months after randomization

• Rate of readmission for any cause

  6 months after randomization

• Rate of cardiac implantable electronic device extraction

  6 months after randomization

• Rate of relapse bacteremia (the same microorganism)

  6 months after randomization

Study Arms (2)

Cardiac implantable electronic device removal + empirical antibiotic therapy

EXPERIMENTAL

CIED removal + guideline antibiotic therapy (at least 10 days iv antibiotic therapy and then per oral treatment to 6 weeks total by POET criteria). The antibiotic therapy is targeted according to microbiological analyses per microorganism. The CIED removal will be done as soon as possible within 7 days.

Procedure: Cardiac implantable electronic device extraction

Empirical antibiotic therapy

NO INTERVENTION

Guideline antibiotic therapy (at least 10 days iv antibiotic therapy and then per oral treatment to 6 weeks total by POET criteria). The antibiotic therapy is targeted according to microbiological analyses per microorganism.

Interventions

Cardiac implantable electronic device extraction PROCEDURE

The CIED removal will be done as soon as possible within 7 days.

Cardiac implantable electronic device removal + empirical antibiotic therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Possible CIED infection\*
• AND
• Bacteremia/fungemia with S. aureus detected in ≥1 positive blood culture(s) or CoNS, Cutibacterium spp., Candida spp, Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis detected in ≥2 positive blood cultures.
• Left-sided valve infective endocarditis
• AND
• Possible CIED infection\*
• AND
• Bacteremia/fungemia detected in ≥1 positive blood culture(s) with S. aureus, CoNS, Cutibacterium spp., Candida spp., Streptococcus spp. (except Streptococcus pneumoniae), and Enterococcus faecalis

You may not qualify if:

• Unavailable for follow-up (e.g. tourist)
• Unwilling to sign informed consent
• Unable to sign informed consent
• At least one of the following criteria
• Not a candidate by clinician discretion
• Definite CIED infection\*
• Clinical frailty score ≥7
• EUROSCORE II \>33%
• Forced expiratory volume in one second (FEV1) \<1L or \<30% of expected
• By the modified Duke and ESC diagnostic criteria

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emil L Fosbøl, MD, PhD

  Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emil L Fosbøl, MD, PhD

CONTACT

+4535456340; emil.fosboel@regionh.dk

Amna Alhakak, MD

CONTACT

amna.alhakak.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Randomized open label trial

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 21, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 31, 2038
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)