One or two infusions could replace weeks of antibiotics for heart infection

NCT ID NCT07699211

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 184 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Deutsches Herzzentrum der Charité (DHZC)

    Berlin, State of Berlin, 13353, Germany

  • Helios Klinikum Erfurt GmbH

    Erfurt, Thuringia, 99089, Germany

  • Klinikum St. Gerog gGmbh

    Leipzig, Saxony, 04129, Germany

  • University Hospital Jena

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93053, Germany

  • Vivantes Auguste-Viktoria-Klinikum

    Berlin, State of Berlin, 12157, Germany

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