Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
NCT ID: NCT05958290
Last Updated: 2025-07-28
Study Results
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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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-09-01
2026-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Discontinuation of antibiotics
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.
Standard treatment
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.
Eligibility Criteria
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Inclusion Criteria
* Deemed non-eligible for CIED extraction
Exclusion Criteria
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Emil Loldrup Fosbol
Professor
Locations
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Rigshospitalet
Copenhagen, Capital Region, Denmark
Countries
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Facility Contacts
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Other Identifiers
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H-23029723
Identifier Type: -
Identifier Source: org_study_id
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