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Dalbavancin versus standard drug combination for treatment of infective endocarditis caused by Gram‑positive cocci in adult patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with infective endocarditis, an infection of the heart’s inner lining, that is caused by Gram‑positive cocci – a group of round‑shaped bacteria such as staphylococci, streptococci and enterococci. The investigational medication is dalbavancin, which is given by a single intravenous (IV) infusion, and it is being compared with the usual standard antibiotic therapy that typically includes drugs like vancomycin given through an IV line and may later be changed to oral antibiotics. The purpose of the study is to determine whether treatment with dalbavancin improves treatment success at day 90 compared with standard therapy.

Participants who meet the study criteria are randomly assigned to receive either the single‑dose dalbavancin infusion or the conventional antibiotic regimen. After the initial treatment, patients remain in the hospital for monitoring and then are discharged with scheduled follow‑up visits to check for any heart complications, repeat infections, or the need for heart surgery. Follow‑up assessments are performed at several time points up to 90 days (and later at one year) and include simple health questionnaires and basic examinations to evaluate recovery and any side effects. Throughout the study, safety checks are made to ensure the medication is well tolerated.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After you agree to join the study, you sign a consent form that explains the purpose, procedures, and possible risks.

    Your baseline health information is recorded, including medical history and current medications.

  2. Step 2

    Baseline assessments

    Clinical examination, blood tests, and imaging are performed to confirm infective endocarditis caused by gram‑positive cocci.

    Nasopharyngeal and rectal swabs or stool samples are collected for microbiome and resistance analysis.

  3. Step 3

    Randomization

    You are assigned by the study system to receive either the test medication dalbavancin or the standard antibiotic therapy.

    The assignment is not influenced by you or the clinical team.

  4. Step 4

    Administration of study medication

    If you are assigned to the test group, you receive a single intravenous infusion of dalbavancin 1500 mg.

    If you are assigned to the standard‑therapy group, you receive the recommended antibiotics for gram‑positive endocarditis, which may include one or more of the following:

    levofloxacin 1 g iv, ceftriaxone 4 g iv, amoxicillin 6 g oral, doxycycline 0.3 g oral, rifampicin 1.2 g oral, and other agents listed in the protocol. each drug is given at the dose shown and administered by the route indicated (intravenous or oral) for the duration determined by the treating physician.

  5. Step 5

    Hospital stay and monitoring

    You remain in the hospital while receiving the assigned antibiotics.

    Clinical status, vital signs, and laboratory results are checked regularly.

    Any adverse events are recorded from the first dose (day 0) until 14 days after the end of therapy (eot+14).

  6. Step 6

    Follow‑up visits

    A follow‑up visit is scheduled at day 90 to assess outcome using the desirability of outcome ranking (door) and to collect health‑economic data, neurological scores, quality‑of‑life questionnaires, and repeat swabs.

    Additional assessments are performed at 1 year for long‑term outcomes, including mortality, cardiac surgery, infectious complications, embolic events, and frailty score.

  7. Step 7

    Study completion

    After the 1‑year visit, all study data are finalized.

    You receive a summary of the study results if you wish to be informed.

Who can join the trial?

3 criteria

  • You must be at least 18 years old.
  • You must sign a written informed consent form, which means you agree to join the study after it is explained to you.
  • You must have a confirmed infection of the inner lining of the heart (called infective left‑sided endocarditis) that involves the mitral valve or aortic valve. The infection can be on a natural valve (native) or an artificial valve (prosthetic) and must be caused by certain bacteria known as Gram‑positive cocci (these include staphylococci, streptococci, or enterococci) that can be treated with the medication dalbavancin.

Who cannot join the trial?

18 criteria

  • Hemodynamic instability requiring medication to raise blood pressure (called vasopressor therapy) within the last 72 hours before joining the study.
  • Being on continuous kidney‑cleaning treatment (a type of dialysis called continuous renal replacement therapy, such as CVVHD or CVVHDF).
  • Having moderate to severe liver scarring known as Child B or C liver cirrhosis.
  • Receiving palliative care, which focuses on comfort rather than trying to cure the illness.
  • Having another infection that would need a longer course of antibiotics than the one planned for the heart infection.
  • Already taking oral (pill) antibiotics for the current episode of endocarditis before randomization.
  • Having heart surgery scheduled after randomization that would occur during the planned antibiotic treatment period.
  • Having an abscess (a pocket of pus) in the spine or brain larger than 0.5 cm.
  • Being pregnant or breastfeeding.
  • Being a woman who could become pregnant unless one of the following applies: you are post‑menopausal, you have had both ovaries removed, you use a reliable birth‑control method, you are abstinent, or your partner has had a vasectomy.
  • Having a fever (body temperature ≥ 38.0 °C) within the 72 hours before randomization.
  • Having a positive blood test that shows bacteria growing (called a blood culture) within the 72 hours before randomization.
  • Having an abscess inside the heart at the time of randomization.
  • Having an infected heart device such as a cardiovascular implantable electronic device (CIED), an infected blood‑vessel graft, or an infected TAVI prosthesis at the time of randomization.
  • Having received less than 7 days of effective intravenous (through a vein) antibiotic treatment for endocarditis before randomization.
  • Having less than 10 days of antibiotic treatment left to complete the therapy for endocarditis.
  • Being allergic (having hypersensitivity) to dalbavancin, vancomycin, teicoplanin, or any component of the study drug.
  • Participating in another clinical trial without prior approval from the study sponsors.
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Investigated drugs

  • Dalbavancin

    is the experimental drug being tested. It is given by injection into a vein and is designed to kill Gram‑positive bacteria that cause infective endocarditis. The study looks at whether a single or short‑course of dalbavancin can cure the infection as well as, or better than, the usual longer antibiotic regimens.

  • Levofloxacin

    is a fluoroquinolone antibiotic that can be given by mouth or by IV. In this trial it is used as part of the standard therapy to treat the heart infection, helping to eliminate the bacteria that cause the disease.

  • Benzylpenicillin potassium

    (often called penicillin G) is an injectable antibiotic that works against many types of bacteria. In the study it is one of the conventional drugs used to treat endocarditis caused by Gram‑positive organisms.

  • Doxycycline

    is an oral antibiotic that can also be given by IV. It is included in the comparator group to provide coverage against the bacterial infection in patients receiving standard treatment.

  • Daptomycin

    is a powerful IV antibiotic that kills Gram‑positive bacteria, including those that are resistant to other drugs. It is used as a standard option for treating serious heart infections in the control arm of the trial.

  • Ciprofloxacin

    is a fluoroquinolone antibiotic available in both IV and oral forms. It is part of the usual antibiotic regimen used for comparison with dalbavancin.

What is already known about the treatment

  • Levofloxacin

    Levofloxacin is given by injection into a vein or taken as a tablet, and it is an approved antibiotic used worldwide. It treats many bacterial infections such as pneumonia, urinary‑tract infections, and skin infections. The drug works by stopping the bacteria from copying their DNA, which stops them from growing. It belongs to the fluoroquinolone class of antibiotics.

  • Benzylpenicillin potassium

    This medicine is given by injection into a vein and is a long‑standing, approved penicillin antibiotic. It is used mainly for serious infections like meningitis, pneumonia, and infections of the heart lining. It kills bacteria by breaking down the wall that protects them. It is classified as a natural penicillin.

  • Doxycycline

    Doxycycline can be taken as a tablet or given by injection, and it is an approved broad‑spectrum antibiotic. It is used for infections such as Lyme disease, acne, and respiratory infections. The drug blocks the bacteria’s ability to make proteins, which stops their growth. It belongs to the tetracycline class.

  • Daptomycin

    Daptomycin is administered by intravenous infusion and is an approved antibiotic for serious Gram‑positive infections. It is used for skin infections, bloodstream infections, and certain heart infections. Daptomycin works by creating holes in the bacterial cell membrane, causing the bacteria to die. It is classified as a lipopeptide antibiotic.

  • Ciprofloxacin

    Ciprofloxacin can be given by injection or taken as a tablet, and it is an approved fluoroquinolone antibiotic. It treats urinary‑tract infections, abdominal infections, and some respiratory infections. The drug stops bacterial DNA from being copied, which stops bacterial growth. It belongs to the fluoroquinolone class.

  • Cefotaxime

    Cefotaxime is given by intravenous infusion and is an approved third‑generation cephalosporin antibiotic. It is used for severe infections such as meningitis, pneumonia, and abdominal infections. It works by interfering with the building of the bacterial cell wall, causing the bacteria to burst. It is classified as a cephalosporin.

Investigated diseases

Infective endocarditis - It is an infection of the inner lining of the heart and its valves. Bacteria from the bloodstream, especially Gram‑positive cocci such as staphylococci, streptococci, and enterococci, attach to damaged heart tissue. The infection causes fever, fatigue, and inflammation of the heart lining. Over days to weeks, the bacteria multiply and can create small clumps on the valves, leading to worsening valve function. If untreated, the condition can gradually spread and cause more serious heart problems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526149-91-00Protocol codeZKSJ0165Estimated enrolment166 patientsSponsorFriedrich-Schiller-Universitaet Jena

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