New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System

Phase 3

Recruiting

• Conditions: Endocarditis, Bacterial
• Interventions: Other: Timing of reimplantation

• Registration Number: NCT06250985
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Study Start: 2024-04-01
• Primary Completion: 2027-12-31
• Study Completion: 2037-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Culture positive or negative infection of a CIED acording to PI
• Indication for removal of device
• Indictation for reimplantation of new device
• A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate reimplantation	Timing of reimplantation	Reimplantation in same procedure as removal of device or shortly thereafter.
Standart care	Timing of reimplantation	Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared

Primary Outcome Measures

Name	Time	Method
Composite primary outcome	within 6 months of randomization	Composite endpoint consisting of number of participants with one or more of the following events during follow-up: death, symptomatic embolism (systemic or pulmonary), bacteremia or pocket infection with same bacterial pathogen or removal of device due to new infection.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark