One or two infusions could replace weeks of antibiotics for heart infection
NCT ID NCT07699211
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This study compares a long-acting antibiotic called dalbavancin to standard therapy for treating infective endocarditis, a serious infection of the heart valves caused by certain bacteria. Dalbavancin is given as one or two intravenous infusions, while standard therapy requires daily antibiotics for weeks. The trial includes 184 adults with left-sided heart valve infections and measures outcomes like survival, complications, and hospital stay length.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dalbavancin
- What this could lead to
- If successful, this could offer a simpler treatment option for endocarditis, potentially reducing hospital stays with just one or two infusions instead of weeks of daily antibiotics.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all patients, especially those with unstable conditions. Dalbavancin may not be as effective as standard therapy for all types of heart valve infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 184 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥ 18 years 2. written informed consent 3. 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. Exclusion Criteria: 1. Hemodynamic instability requiring vasopressor therapy within the last 72 hours prior to randomization 2. Body temperature ≥38.0°C within the 72 hours prior to randomization 3. Evidence of pathogen growth in a blood culture within the 72 hours prior to randomization 4. Presence of a cardiac abscess at the time of randomization 5. 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 6. Duration of effective intravenous antibiotic therapy for endocarditis of \< 7 days prior to randomization 7. 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) 8. Hypersensitivity to dalbavancin, vancomycin, teicoplanin, or other components of the investigational drug 9. 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 10. Continuous renal replacement therapy (e.g., CVVHD, CVVHDF) 11. Child B or C liver cirrhosis 12. Palliative care 13. Secondary infections requiring a longer course of antibiotic therapy than that intended for the treatment of endocarditis 14. Oral antibiotic therapy already initiated to treat the current episode of endocarditis 15. Scheduled cardiac surgery after randomization, within the period designated for antibiotic treatment of endocarditis 16. Intraspinal or brain abscess (\> 0.5 cm) 17. Pregnant and breastfeeding women 18. Women of childbearing potential, unless the following criteria are met: 1. Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH \> 40 mIU/mL) 2. Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy) 3. 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) 4. sexual abstinence 5. Vasectomy of the partner
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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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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Klinikum St. Gerog gGmbh
Leipzig, Saxony, 04129, Germany
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University Hospital Jena
Jena, Thuringia, 07747, Germany
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Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, 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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Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053, Germany
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Vivantes Auguste-Viktoria-Klinikum
Berlin, State of Berlin, 12157, Germany
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