Accelerated Treatment of Endocarditis
Running, not enrolling · Not applicable
Conditions studied: Infectious Endocarditis
In brief
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)
Key facts
- Study ID
- NCT03851575
- Run by
- Rigshospitalet, Denmark
- People needed
- 508
- Starts
- 2019-01-17
- Expected to finish
- 2036-04-28
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Brigham and Womens Hospital — Boston, Massachusetts, United States
- Rigshospitalet — Copenhagen, Denmark, Denmark
- Skejby Sygehus — Aarhus, Denmark
- Bispebjerg Hospital — Copenhagen, Denmark
- Herlev Hoslpital — Copenhagen, Denmark
- Gødstrup Regional Hospital — Gødstrup, Denmark
- Hillerød Hospital — Hillerød, Denmark
- Hvidovre Hospital — Hvidovre, Denmark
- Odense Sygehus — Odense, Denmark
- Roskilde Sygehus, Zealand University hospital — Roskilde, Denmark
- Vejle Hospital — Vejle, Denmark
- Viborg Hospital — Viborg, Denmark
- Skåne University Hospital — Lund, Sweden
Full record on ClinicalTrials.gov
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