Dalbavancin Therapy for Infective Endocarditis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStefan Hagel
About this trial
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.
Eligibility criteria
Qualifiers
≥ 18 years
written informed consent
Confirmed left-sided infective endocarditis (mitral and/or aortic valve) involving native (NV) or prosthetic (PV) valves caused by Gram-positive cocci (staphylococci, streptococci, or enterococci) that are susceptible to dalbavancin.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dalbavancin administration
- Standard of Care (Investigator Choice)
Treatment groups
184 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stefan Hagel
Lead sponsor
Jena University Hospital
Sponsor institution
Source ClinicalTrials.gov