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

March 20, 2024 updated by: Henning Bundgaard, Rigshospitalet, Denmark

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate reimplantation
Reimplantation in same procedure as removal of device or shortly thereafter.
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
Active Comparator: Standart care
Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite primary outcome
Time Frame: 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.
within 6 months of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Henning Henning, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2037

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23033548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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