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Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci
EU CTIS ID: 2026-526149-91-00
What this study is testing
The objective of the study is to determine whether treatment with dalbavancin improves treatment success at day 90 in patients with endocarditis caused by Grampositive cocci, compared with the recommended standard antibiotic therapy (including sequential intravenous-oral therapy).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 18 years
- written informed consent
- Confirmed infective left-sided 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 likely can't join if
- Hemodynamic instability requiring vasopressor therapy within the last 72 hours 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
See the full eligibility criteria
- ≥ 18 years
- written informed consent
- Confirmed infective left-sided 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.
- Hemodynamic instability requiring vasopressor therapy within the last 72 hours 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: a. Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 mIU/mL) b. Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy) c. 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) d. sexual abstinence e. Vasectomy of the partner
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.