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

Endocarditis, Bacterial Clinical Trial

— POET-PPM  

Official title:

New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250985
• Other study ID #: H-23033548
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: December 31, 2037

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: Henning Bundgaard, MD, DMSc
• Phone: 35453534
• Email: henning.bundgaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 31, 2037
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite primary outcome	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.	within 6 months of randomization