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NCT Number: NCT05144399

Accelerated Treatment of Endocarditis

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Endocarditis Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skejby Sygehus, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria.
  • The patient may be included <14 days after beginning of relevant antibiotic treatment.
  • Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus.
  • Patients ≥ 18 years.

Exclusion criteria

  • Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (> 20 mg / day)).
  • Incapability to give informed consent for participation.
  • Relapse Endocarditis (Endocarditis with the same bacteria within six months).

Treatment and study plan

Accelerated antibiotic treatment

Other

E. faecalis uncomplicated: 4 weeks.

E. faecalis complicated: 4 weeks.

S. aureus uncomplicated: 2 weeks.

S. aureus complicated: 4 weeks.

Streptococci spp. NVE: 2 weeks.

Streptococci spp. PVE or abscess: 3 weeks.

Subsequent to cardiac surgery with a negative valve culture (organism NOT grown in laboratory from valve): Minimum 1 week after surgery regardless of previous antibiotic treatment received.

Subsequent to cardiac surgery with a positive valve culture (organism grown in laboratory from valve): treatment will continue with the start date of antibiotics changed to the date of surgery.

Complicated IE defined as patients with abscess, embolic event, surgically treated IE, and/or PVE.

NVE: native valve endocarditis, PVE: prosthetic valve endocarditis.

Standard treatment length

Other

E. faecalis uncomplicated: 6 weeks.

E. faecalis complicated: 6 weeks.

S. aureus uncomplicated: 4 weeks.

S. aureus complicated: 6 weeks.

Streptococci spp. NVE: 4 weeks.

Streptococci spp. PVE or abscess: 6 weeks.

Subsequent to cardiac surgery with a negative valve culture (organism NOT grown in laboratory from valve): Minimum 2 weeks after surgery regardless of previous antibiotic treatment received.

Subsequent to cardiac surgery with a positive valve culture (organism grown in laboratory from valve): treatment will continue with the start date of antibiotics changed to the date of surgery.

Complicated IE defined as patients with abscess, embolic event, surgically treated IE, and/or PVE.

NVE: native valve endocarditis, PVE: prosthetic valve endocarditis.

Primary outcomes

  1. Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery

    Time frame: 6 months after randomization

    The primary endpoint is a combined endpoint consisting of the following events occurring within six months after the earliest time of potential treatment discontinuation: Death; Embolisms; Heart surgery not planned at the time of randomization.

  2. Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups

    Time frame: 6 months after randomization

    The primary efficacy endpoint is the difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups, assessed from and until 6 months after randomization.

Secondary outcomes

  1. Expenses associated with admission and treatment

    Time frame: 6 months after randomization

    Combined endpoint consisting of expenses due to i admission ii medication iii transportation iv surgery v imaging vi home care

  2. Duration of admission

    Time frame: 6 months after randomization

    Duration of admission

  3. Duration of antibiotic treatment

    Time frame: 6 months after randomization

    Duration of antibiotic treatment

  4. Frequency of catheter complication

    Time frame: 6 months after randomization

    Frequency of catheter complication

  5. Unplanned Heart surgery

    Time frame: 6 months after randomization

    • Unplanned cardiac valve surgery defined as any cardiac surgery which is not planned at the time of randomization. Data will be extracted from the electronic patient journal.

  6. All cause mortality

    Time frame: 6 months after randomization

    All cause mortality

  7. Embolic events

    Time frame: 6 months after randomization

    Embolic events

  8. Re-bacteremia with the primary pathogen

    Time frame: 6 months after randomization

    • Relapse of bacteremia defined as a positive blood culture with the same microorganism as during the initial IE admission (streptococci spp., S. aureus, or E. faecalis). Data will be extracted from the electronic patient journal.

  9. Quality of life assesment

    Time frame: 6 monts after randomization and after

    Quality of life assessed by completing short version 36 (SF 36) version 2

Other outcomes

  1. Long-term asessment of primary safety outcome consisting of all cause mortality, embolic episodes and not planned heart surgery

    Time frame: 10 years from randomization

    Patients will be followed by medical chart review up to 10 years after randomization for the Combined safety endpoint consisting of death, embolism or unplanned heart valve surgery

  2. Long-term assesment of primary efficacy outcome: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups

    Time frame: 10 years from randomization

    Patients will be followed by medical chart review up to 10 years after randomization for the primary efficacy endpoint consisting number of days alive without antibiotic treatment for endocarditits/and or bacteremia between the two study groups

  3. Long term assesment of the secondary outcome relapse of bacteremia with primary pathogen

    Time frame: 10 years after randomization

    Relapse of bacteremia defined as a positive blood culture with the same microorganism as during the initial IE admission (streptococci spp., S. aureus, or E. faecalis). Data will be extracted from the electronic patient journal.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Bispebjerg Hospital
  • Brigham and Women's Hospital
  • Gødstrup Hospital
  • Hvidovre University Hospital
  • Lund University Hospital
  • Nordsjaellands Hospital
  • Odense University Hospital
  • Regionshospitalet Viborg, Skive
  • Rigshospitalet, Denmark
  • Vejle Hospital
  • Zealand University Hospital

Registry information

Acronym: POET II

Important dates

Study start
2019
Primary completion
2026
Study completion
2036
First posted
Dec 3, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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