EndocarditisPOET IINCT05144399
Accelerated Treatment of Endocarditis
A study testing Accelerated antibiotic treatment and Standard treatment length in people with Endocarditis, run by Herlev Hospital at 13 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis
- What is being tested?
- Accelerated antibiotic treatment and Standard treatment length
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 17 Jan 2019to 28 Apr 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Denmark11 sites
Skejby Sygehus
Aarhus
Rigshospitalet
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen
Gødstrup Regional Hospital
Gødstrup
Herlev Hospital
Herlev, 2730
Hillerød Hospital
Hillerød
Hvidovre Hospital
Hvidovre
Odense sygehus
Odense
Roskilde Sygehus, Zealand University hospital
Roskilde
Vejle Hospital
Vejle
Viborg Hospital
Viborg
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02115
About this study
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).
- Conditions
- Endocarditis
- Being tested
- Accelerated antibiotic treatment, Standard treatment length
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated antibiotic treatmentOther
- faecalis uncomplicated: 4 weeks.
- faecalis complicated: 4 weeks.
- aureus uncomplicated: 2 weeks.
- 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 lengthOther
- faecalis uncomplicated: 6 weeks.
- faecalis complicated: 6 weeks.
- aureus uncomplicated: 4 weeks.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated antibiotic treatment | Experimental | Patients are treated shorter than usual Receives: Other: Accelerated antibiotic treatment |
| Standard length of antibiotic treatment | Other | Patients are receiving the standard length of antibiotic treatment Receives: Other: Standard treatment length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery
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.
Measured: 6 months after randomization
Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups
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.
Measured: 6 months after randomization
Secondary outcomes (9)
Expenses associated with admission and treatment
Combined endpoint consisting of expenses due to i admission ii medication iii transportation iv surgery v imaging vi home care
Measured: 6 months after randomization
Duration of admission
Duration of admission
Measured: 6 months after randomization
Duration of antibiotic treatment
Duration of antibiotic treatment
Measured: 6 months after randomization
Frequency of catheter complication
Frequency of catheter complication
Measured: 6 months after randomization
Unplanned Heart surgery
- 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.
Measured: 6 months after randomization
All cause mortality
All cause mortality
Measured: 6 months after randomization
Embolic events
Embolic events
Measured: 6 months after randomization
Re-bacteremia with the primary pathogen
- 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.
Measured: 6 months after randomization
Quality of life assesment
Quality of life assessed by completing short version 36 (SF 36) version 2
Measured: 6 monts after randomization and after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start17 Jan 2019
- Primary completion28 Apr 2026
- Study completion28 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- 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, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Kasper Iversen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144399
- Sponsor's protocol ID
- H-18028566
- Other IDs
- ID NCT03851575
- Acronym
- POET II
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Treatment of Endocarditis
- ClinicalTrials.gov ID
- NCT05144399
- Acronym / sponsor ID
- POET II / H-18028566
- Conditions
- Endocarditis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- 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, Copenhagen University Hospital, Rigshospitalet
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2036 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated antibiotic treatment | Experimental | Other: Accelerated antibiotic treatmentPatients are treated shorter than usual |
| Standard length of antibiotic treatment | Other | Other: Standard treatment lengthPatients are receiving the standard length of antibiotic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated antibiotic treatmentE. 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. | Other | Accelerated antibiotic treatment |
| Standard treatment lengthE. 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. | Other | Standard length of antibiotic treatment |
Primary outcome
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.
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.
9 secondary outcomes
Expenses associated with admission and treatment
Time frame: 6 months after randomization
Duration of admission
Time frame: 6 months after randomization
Duration of antibiotic treatment
Time frame: 6 months after randomization
Frequency of catheter complication
Time frame: 6 months after randomization
Unplanned Heart surgery
Time frame: 6 months after randomization
All cause mortality
Time frame: 6 months after randomization
Embolic events
Time frame: 6 months after randomization
Re-bacteremia with the primary pathogen
Time frame: 6 months after randomization
Quality of life assesment
Time frame: 6 monts after randomization and after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated antibiotic treatment and Standard treatment length in people with Endocarditis, run by Herlev Hospital at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Denmark, United States, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery (time frame: 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.