Endocarditis, BacterialPhase 3POET-PPMNCT06250985
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
A Phase 3 study testing Timing of reimplantation in people with Endocarditis, Bacterial, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Endocarditis, Bacterial
- What is being tested?
- Timing of reimplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 5 sitesDenmark
- Study dates
- 29 Apr 2024to 31 Dec 2037
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mia M Pries-Heje, MD, PhD contact
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, North Denmark
Gergely Klausz, MD, 004597 66 45 22, g.klausz@rn.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Henning Bundgaard, MD, +45 3545 0512, Henning.Bundgaard@Regionh.DK
- Recruiting
Bispebjerg-Frederiksberg Hospital
Frederiksberg, Copenhagen, 2000
Christian Tuxen, MD, PhD, 004521298430, Christian.Ditlev.Tuxen@regionh.dk
- Recruiting
Herlev-Gentofte Hospital
Herlev, 2730
Kasper Iversen, MD, PhD, 004528712753, Kasper.Karmark.Iversen@regionh.dk
- Recruiting
Hilleroed Hospital
Hillerød, Nordsjaelland, 3400
Malene Wienberg, MD, PhD, 004548293299, malene.wienberg@regionh.dk
About this study
Official title: 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
- Conditions
- Endocarditis, Bacterial
- Being tested
- Timing of reimplantation
- Medical subject headings
- Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of reimplantationOther
Patients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system
| Study group | Role | What they receive |
|---|---|---|
| Immediate reimplantation | Experimental | Reimplantation in same procedure as removal of device or shortly thereafter. Receives: Other: Timing of reimplantation |
| Standart care | Active comparator | Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared Receives: Other: Timing of reimplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start29 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis, BacterialStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Bundgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henning Henning, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250985
- Sponsor's protocol ID
- H-23033548
- Acronym
- POET-PPM
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No