AzTrials
AzTrials

Infectious EndocarditisPOETIINCT03851575

Accelerated Treatment of Endocarditis

A study testing Accelerated treatment of endocarditis and Usual guideline therapy in people with Infectious Endocarditis, run by Copenhagen University Hospital, Rigshospitalet at 13 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Infectious Endocarditis
What is being tested?
Accelerated treatment of endocarditis and Usual guideline therapy
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, 8200

  • Rigshospitalet

    Copenhagen, Denmark, 2100

  • Bispebjerg Hospital

    Copenhagen

  • Herlev Hoslpital

    Copenhagen

  • Gødstrup Regional Hospital

    Gødstrup

  • Hillerød Hospital

    Hillerød

  • Hvidovre Hospital

    Hvidovre

  • Odense Sygehus

    Odense, 5000

  • Roskilde Sygehus, Zealand University hospital

    Roskilde

  • Vejle Hospital

    Vejle

  • Viborg Hospital

    Viborg

Other trials in Denmark

United States1 site

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

Other trials in United States

Sweden1 site

  • Skåne University Hospital

    Lund

Other trials in Sweden

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)

Being tested
Accelerated treatment of endocarditis, Usual guideline therapy
Medical subject headings
Endocarditis, Subacute Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accelerated treatment of endocarditisOther

    1. 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.

  • Usual guideline therapyOther

    1. 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.
Study groups in NCT03851575
Study groupRoleWhat they receive
Control armActive comparatorUsual guideline therapy
Receives: Other: Usual guideline therapy
Accelerated armExperimentalAccelerated treatment of endocarditis
Receives: Other: Accelerated treatment of endocarditis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 monts after randomization

  2. 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)

  1. Expenses

    Expenses associated with hospitalization and treatment of the disease. I.E., expenses to admission, examinations and medicine

    Measured: 6 monts after randomization

  2. Duration of antibiotic treatment

    Duration of antibiotic treatment

    Measured: 6 months after randomization

  3. Duration of hospitalization

    Duration of hospitalization

    Measured: 6 monts after randomization

  4. Frequency of catheter complication

    Frequency of catheter complication

    Measured: 6 months after randomization

  5. Surgery not planned at randomization

    Number of patients that have Surgery not planned at randomization

    Measured: 6 monts after randomization

  6. Death

    Number of patients that die

    Measured: 6 monts after randomization

  7. Embolisms

    Number of patients that have an embolism

    Measured: 6 monts after randomization

  8. Bacteraemia with the same microorganism,

    Number of patients that have Bacteraemia with the same microorganism

    Measured: 6 monts after randomization

  9. 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.

  1. First posted22 Feb 2019
  2. Study start17 Jan 2019
  3. Primary completion28 Apr 2026
  4. Study completion28 Apr 2036 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851575
Sponsor's protocol ID
H-18028566
Other IDs
ID NCT05144399
Acronym
POETII
Status last verified
Jul 2026
First submitted
3 Dec 2018
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bundgaard H, Pries-Heje M, Hjulmand J, Hasselbalch R, Jorgensen PG, Fano S, Kober N, Tuxen C, Kader N, Seven E, Rasmussen LE, Wienberg M, Bruun NE, Tofterup M, Rasmussen M, Baden LR, Woolley A, Lange T, Helweg-Larsen J, Povlsen JA, Fosbol E, Moser C, Iversen K; POET II Investigators. Response-Tailored or Standard-Duration Antibiotic Treatment for Infective Endocarditis. N Engl J Med. 2026 Aug 28. doi: 10.1056/NEJMoa2607887. Online ahead of print.

    PubMed 42663314

Questions about this trial

What is this clinical trial studying?

A study testing Accelerated treatment of endocarditis and Usual guideline therapy in people with Infectious Endocarditis, run by Copenhagen University Hospital, Rigshospitalet 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 monts 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?

On the ClinicalTrials.gov record for NCT03851575, which also lists 1 linked publication.

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.

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