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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526149-91-00 | EU Trial (CTIS) Number |
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This study compares two treatment strategies for antibiotic therapy in endocarditis. The aim of the study is to determine which treatment is more effective overall and better tolerated by patients.
The first strategy is standard therapy: treatment with proven antibiotics, which are usually administered initially as an intravenous infusion in the hospital and can be switched to oral therapy with tablets later on for suitable patients.
The second strategy is the study treatment with dalbavancin: This is a long-acting antibiotic. It is administered as a single infusion; for longer treatment durations, a second infusion may be necessary 14 days later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | Dalbavancin 500 mg; intravenous, 30-minute infusion duration per administration |
|
| control group | Other | Therapy in accordance with the recommendations of the current European Society of Cardiology (ESC) guidelines for the treatment of endocarditis, including oral sequential therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalbavancin administration | Drug | Dosage: Total dose depending on the required duration of therapy for endocarditis Route of administration: intravenous, 30-minute infusion duration per administration Frequency: Day 0 and, if necessary, an additional administration on Day 14 ± 2 days, depending on the required duration of therapy for endocarditis Duration of treatment: depending on the required duration of therapy for endocarditis (2-5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy | Five possible DOOR ratings are distinguished:
Door events include:
| Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (days) | Day 90 | |
| National Institutes of Health Stroke Scale (NIHSS) | Scores range from 0 to 42, where 0 indicates normal function and higher numbers reflect greater impairment |
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Inclusion Criteria:
Exclusion Criteria:
Hemodynamic instability requiring vasopressor therapy within the last 72 hours prior to randomization
Body temperature ≥38.0°C within the 72 hours prior to randomization
Evidence of pathogen growth in a blood culture within the 72 hours prior to randomization
Presence of a cardiac abscess at the time of randomization
Presence of a remaining infected cardiovascular implantable electronic device (CIED), an infected intravascular graft, or an infected TAVI prosthesis ("TAVI endocarditis") at the time of randomization
Duration of effective intravenous antibiotic therapy for endocarditis of < 7 days prior to randomization
Remaining duration of required antibiotic therapy for the treatment of endocarditis is less than 10 days (i.e., remaining treatment duration must be at least 10 days)
Hypersensitivity to dalbavancin, vancomycin, teicoplanin, or other components of the investigational drug
Participation in another clinical interventional trial under the German Medicines Act (AMG), Medical Devices Regulation (MDR), or Medical Devices Act (MPDG) without prior consultation and approval by the respective sponsors prior to randomization
Continuous renal replacement therapy (e.g., CVVHD, CVVHDF)
Child B or C liver cirrhosis
Palliative care
Secondary infections requiring a longer course of antibiotic therapy than that intended for the treatment of endocarditis
Oral antibiotic therapy already initiated to treat the current episode of endocarditis
Scheduled cardiac surgery after randomization, within the period designated for antibiotic treatment of endocarditis
Intraspinal or brain abscess (> 0.5 cm)
Pregnant and breastfeeding women
Women of childbearing potential, unless the following criteria are met:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Hagel, PD Dr. | Contact | +4936419324590 | stefan.hagel@med.uni-jena.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| D004697 | Endocarditis, Bacterial |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care (Investigator Choice) | Drug | Therapy in accordance with the recommendations of the current European Society of Cardiology (ESC) guidelines for the treatment of endocarditis, including oral sequential therapy Test drug: depending on pathogen, resistance, and comorbidities Dosage: depending on pathogen, resistance, and comorbidities Route of administration: intravenous, including oral sequential therapy Duration of treatment: depending on the required treatment duration for endocarditis (2-5 weeks) |
|
| Day 90 and 1 year |
| PROMIS-29 domain-specific T-scores and pain intensity | The PROMIS-29 assesses physical, mental, and social health using 7 domains (4 items each) and pain intensity (1 item). A higher Domain-Specific T-Score (scale range 20-80) means a better outcome for functional domains (Physical Function, Social Roles) but a worse outcome for symptom domains (Anxiety, Depression, Fatigue, Sleep Disturbance). Pain intensity is recorded on an 11-point numeric scale (0-10, where 0 is "no pain" and 10 is "worst imaginable"). | Day 90 and 1 year |
| Overall mortality | Day 90 and 1 year |
| Cardiac surgery | Day 90 and 1 year |
| Infectious complications | Day 90 and 1 year |
| Embolic event | Day 90 and 1 year |
| Clinical Frailty Scale | The Clinical Frailty Scale (CFS) ranges from a minimum of 1 (representing "very fit") to a maximum of 9 (representing "terminally ill"), meaning a higher score indicates a WORSE outcome (reflecting a higher level of frailty). | Day 90 and 1 year |
| Occurrence of treatment-related adverse events | Baseline to End of Therapy +14 days |
| Dalbavancin Plasma Concentration | Through level, mg/l | Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35 |
| Microbiome analysis | Shannon Diversity Index, 1-5 range, Generally, a higher score indicates a BETTER outcome | Baseline, Day 90 and 1 year |
| Cost of antibiotic therapy | Day 90 |
| Number of days of work disability | Day 90 |
| modified Rankin Scale (mRS) | 7-point clinical scale used to measure the degree of disability or dependence in the daily activities. Scores range from 0 (no symptoms) to 6 (dead) | Day 90 and 1 year |
| EQ-5D-5L index | EuroQuality of Life Five Dimensions (EQ-5D-5L), the descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), with five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. | Day 90 and 1 year |
| Reintegration to Normal Living Index (RNLI) | The Reintegration to Normal Living Index (RNLI) Total Adjusted Score ranges from a minimum of 0 to a maximum of 100, meaning a higher score indicates a BETTER outcome (reflecting full or complete reintegration into normal social activities | Day 90 and 1 year |
| Universitätsklinikum Regensburg | Regensburg | Bavaria | 93053 | Germany |
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| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
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| Klinikum St. Gerog gGmbh | Leipzig | Saxony | 04129 | Germany |
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| Vivantes Auguste-Viktoria-Klinikum | Berlin | State of Berlin | 12157 | Germany |
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| Deutsches Herzzentrum der Charité (DHZC) | Berlin | State of Berlin | 13353 | Germany |
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| Helios Klinikum Erfurt GmbH | Erfurt | Thuringia | 99089 | Germany |
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| University Hospital Jena | Jena | Thuringia | 07747 | Germany |
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| D007239 | Infections |
| D053821 | Cardiovascular Infections |