Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See

NCT ID: NCT05958290

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Implantable Electronic Device Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Discontinuation of antibiotics

Group Type EXPERIMENTAL

Discontinuation of antibiotics

Intervention Type OTHER

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

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unavailable for follow-up (e.g., tourist)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Emil Loldrup Fosbol

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Emil L Fosbøl

Role: primary

004535456340

Other Identifiers

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H-23029723

Identifier Type: -

Identifier Source: org_study_id

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