New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Timing of reimplantation.
- Who it may be relevant to
- Registry conditions: Endocarditis, Bacterial. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System
Overview
The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date. The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of * Death * Symptomatic embolism (systemic arterial embolism or pulmonary embolism) * Bacteremia og pocket-infection * Removal of a CIED due to new infection
Interventions
- Other Timing of reimplantation
Patients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system
Primary outcome measures
- Composite primary outcome [Time frame: within 6 months of randomization]
Eligibility criteria
Inclusion criteria
- Culture positive or negative infection of a CIED acording to PI
- Indication for removal of device
- Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).
- Indication for reimplantation of new device
- A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered and/or culture negative antibiotic regimen have been adminstered until blood culture is examined.
- stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC < 15 mia/L or reduction of min. 25% and III) CRP <50 or min. 25% reduction.
Exclusion criteria
- Immunoincompetence (active chemotherapy or prednisone treatment > 20mg/day
- Device-infection within last 6 months (relaps)
- Septic shock
- Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06250985 · H-23033548