NCT05958290

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Sep 2023Nov 2026

First Submitted

Initial submission to the registry

July 5, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

July 5, 2023

Last Update Submit

July 23, 2025

Conditions

Cardiac Implantable Electronic Device Infection

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of death or relapse bacteremia

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

    12 months

Secondary Outcomes (4)

  • Death

    12 months

  • Readmission for any cause

    12 months

  • Device extraction

    12 months

  • Change in quality of life

    12 months

Study Arms (2)

Discontinuation of antibiotics

EXPERIMENTAL
Other: Discontinuation of antibiotics

Standard treatment

NO INTERVENTION

Interventions

Discontinuation of antibioticsOTHER

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

Discontinuation of antibiotics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 24, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)