Dalbavancin Therapy for Infective Endocarditis

Starting soon · Phase 3

Conditions studied: Endocarditis Infective, Endocarditis, Bacterial

In brief

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.

Key facts

Study ID

NCT07699211

Run by

Stefan Hagel

People needed

184

Starts

2026-12-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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:
• Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 mIU/mL)
• Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy)
• Regular and correct use of a contraceptive method with a failure rate < 1% per year (considered reliable contraceptive methods include oral hormonal contraception, dermal hormonal contraception, contraceptive patches, long-acting injectable contraceptives, progesterone-releasing implants (Implanon®), intramuscular progesterone, tubal ligation (female sterilization), hormone-releasing intrauterine device ("hormonal IUD"), dual barrier methods)
• sexual abstinence
• Vasectomy of the partner

Where it is running

• Universitätsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Universitätsklinikum Regensburg — Regensburg, Bavaria, Germany
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany
• Universitätsklinikum Köln — Cologne, North Rhine-Westphalia, Germany
• Klinikum St. Gerog gGmbh — Leipzig, Saxony, Germany
• Vivantes Auguste-Viktoria-Klinikum — Berlin, State of Berlin, Germany
• Deutsches Herzzentrum der Charité (DHZC) — Berlin, State of Berlin, Germany
• Helios Klinikum Erfurt GmbH — Erfurt, Thuringia, Germany
• University Hospital Jena — Jena, Thuringia, Germany

Full record on ClinicalTrials.gov

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