Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05144399 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Accelerated Treatment of Endocarditis

Study acronym: POET II
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Phase changed: Phase 4 → not applicablev3 Show 9 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites expanded: 2 → 13 locations
    • Primary completion moved earlier from Dec 31, 2026 to Apr 28, 2026
    • Study completion pushed from Dec 31, 2026 to Apr 28, 2036
    • Enrollment target: estimated 475 to confirmed 508
    • Start date: Apr 1, 2019 to Jan 17, 2019
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 8 to 9
    • Collaborators expanded, about 32 words
  2. Notable Enrollment target: 750 to 475
    • Primary and study completion dates: Oct 31, 2022 to Dec 31, 2026
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 5 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
8,786 trials monitored
See 412 trials at risk
Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant financial burden on the health systems. Current guidelines fail to use available clinical and paraclinical, data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the individual patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 475 patients, approx. 125 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus). Interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population. Due to an administrative error, this study has been registered twice on clinicaltrials.gov under identifiers NCT05144399 (original) and NCT03851575 (duplicate). As per July 2026, both records have been updated to unanimously reflect study status and final protocol. Historical versions of the clinicaltrials.gov registration and updates are available under the respective registration ID's (2018-2020 updates under clinicaltrials.gov registration with ID NCT05144399, 2021-2026 updates clinicaltrials.gov registration with ID NCT03851575).
Trial Details
NCT Number NCT05144399
Lead Sponsor Herlev Hospital
Collaborators: Nordsjaellands Hospital, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Lund University Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Vejle Hospital, Regionshospitalet Viborg, Skive, Brigham and Women's Hospital, Gødstrup Hospital, Rigshospitalet, Denmark
Conditions
(from sponsor)
Endocarditis
Related terms Endocarditis
Enrollment 508 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov