New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System (POET-PPM)

Rigshospitalet

Status and phase: Enrolling; Phase 3

Conditions: Endocarditis, Bacterial

Treatments: Other: Timing of reimplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06250985

H-23033548

Details and patient eligibility

About

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

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Immediate reimplantation

Experimental group

Description:

Reimplantation in same procedure as removal of device or shortly thereafter.

Treatment:

Other: Timing of reimplantation

Standart care

Active Comparator group

Description:

Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared

Treatment:

Other: Timing of reimplantation