Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| Nordsjaellands Hospital | OTHER |
| Zealand University Hospital | OTHER |
| Odense University Hospital |
Not provided
Not provided
Not provided
Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks with one or two 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 burden on health systems. Current guidelines fail to use available 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 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 750 patients, approx. 200 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | Usual guideline therapy |
|
| Accelerated arm | Experimental | Accelerated treatment of endocarditis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated treatment of endocarditis | Other | For the three main bacteria species we shorten the duration of antibiotic treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary composite endpoint | Number of patients with at least one of the following: Death (yes/no); Embolisms (yes/no); Bacteraemia with the same microorganism (yes/no), surgery not planned at randomization (yes/no). | 6 monts after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life assessed by completing short version 36 (SF 36) version 2 | 6 monts after randomization and after |
| Expenses | Expenses associated with hospitalization and treatment of the disease. I.E., expenses to admission, examinations and medicine |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kasper K Iversen, MD | Contact | +4528712753 | kasper.k.iversen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Henning Bundgaard, MD | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skejby Sygehus | Recruiting | Aarhus | 8200 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004698 | Endocarditis, Subacute Bacterial |
| ID | Term |
|---|---|
| D004697 | Endocarditis, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
| Aarhus University Hospital | OTHER |
| Lund University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual guideline therapy | Other | Usual guideline therapy |
|
| 6 monts after randomization |
| Duration of hospitalization | Duration of hospitalization | 6 monts after randomization |
| Death | Number of patients that die | 6 monts after randomization |
| Embolisms | Number of patients that have an embolism | 6 monts after randomization |
| Bacteraemia with the same microorganism, | Number of patients that have Bacteraemia with the same microorganism | 6 monts after randomization |
| Surgery not planned at randomization | Number of patients that have Surgery not planned at randomization | 6 monts after randomization |
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
|
| Gentofte Hospital | Recruiting | Copenhagen | Denmark |
|
| Herlev Hoslpital | Recruiting | Copenhagen | Denmark |
|
| Hillerød Hospital | Recruiting | Hillerød | Denmark |
|
| Odense Sygehus | Recruiting | Odense | 5000 | Denmark |
|
| Roskilde Sygehus | Recruiting | Roskilde | Denmark |
|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D053821 | Cardiovascular Infections |
| D002318 | Cardiovascular Diseases |
| D004696 | Endocarditis |
| D006331 | Heart Diseases |