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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum St. Georg gGmbH	Leipzig	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
HELIOS Klinikum Erfurt GmbH	Erfurt	Germany
Unyepalhuw Hxnygopb Cqtxwef	Cologne	Germany
Uvebanyhqb Mhyaesr Cafmjz Hvvuzzqhstnsjbxnr	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.10.2026

Trial locations

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.

Cefotaxime is a third‑generation IV cephalosporin antibiotic that attacks a broad range of bacteria. It is used in the standard therapy arm to help clear the infection.

Amoxicillin is a widely used oral antibiotic that works well against many Gram‑positive bacteria. In the trial it is one of the oral drugs given after an initial IV course as part of the standard treatment.

Ceftriaxone is an IV cephalosporin antibiotic given once daily. It is included in the comparator regimen to provide strong antibacterial activity against the heart infection.

Moxifloxacin is a fluoroquinolone antibiotic that can be taken by mouth or given IV. It is used as an alternative option in the standard therapy group.

Cefalexin is an oral first‑generation cephalosporin antibiotic. It is part of the sequential oral therapy that follows the initial IV treatment in the control arm.

Fosfomycin is an IV antibiotic that works by a different mechanism than many other drugs, helping to treat infections that may be resistant to other antibiotics. It is used as a comparator medication.

Ampicillin is an IV penicillin‑type antibiotic that targets many Gram‑positive bacteria. It is one of the standard drugs used to treat infective endocarditis in the study.

Rifampicin (rifampin) is an oral antibiotic that can also be given IV. It is often combined with other drugs to treat serious infections and is included in the standard treatment arm.

Flucloxacillin is an IV penicillin‑type antibiotic that is especially active against Staphylococcus bacteria. It is used as part of the comparator regimen.

Cefaclor is an oral second‑generation cephalosporin antibiotic. It is given after the initial IV phase as part of the sequential therapy in the control group.

Cefazolin is an IV first‑generation cephalosporin used to treat many Gram‑positive infections. It is included among the standard antibiotics used for comparison.

Ceftaroline fosamil is an IV cephalosporin with activity against resistant Gram‑positive bacteria. It is part of the recommended standard therapy in the trial.

Trimethoprim is an antibiotic that can be taken orally or given IV. It is used in combination with other drugs in the standard treatment arm to help clear the infection.

Imipenem is a broad‑spectrum IV carbapenem antibiotic used for severe infections. In this study it serves as one of the comparator drugs for treating endocarditis.

Sulbactam is an IV beta‑lactamase inhibitor that is often combined with other antibiotics to enhance their effect. It is used as part of the standard regimen.

Sulfamethoxazole is an oral antibiotic (often combined with trimethoprim) that helps fight bacterial infections. It appears in the comparator group as part of the oral therapy.

Linezolid is an oral and IV antibiotic that works against many Gram‑positive bacteria, including those resistant to other drugs. It is one of the options used in the standard treatment arm.

Vancomycin is a powerful IV antibiotic used for serious Gram‑positive infections, especially those resistant to other drugs. It is a key component of the comparator therapy.

Phenoxymethylpenicillin (penicillin V) is an oral penicillin antibiotic used for milder infections but can be part of sequential therapy after IV treatment in the control group.

Gentamicin sulfate is an IV aminoglycoside antibiotic that works well together with other drugs to treat serious infections. It is included in the standard regimen for endocarditis.

Cilastatin is not an antibiotic itself but is combined with the drug imipenem to protect it from breakdown in the body. The combination is used as part of the comparator therapy.

Meropenem is an IV carbapenem antibiotic with very broad activity against many bacteria. It is used as a standard treatment option in the trial.

Clavulanic acid is an oral beta‑lactamase inhibitor that is combined with amoxicillin to overcome resistance. It is part of the oral sequential therapy in the control arm.

Teicoplanin is an IV antibiotic similar to vancomycin, used for serious Gram‑positive infections. It is included among the standard antibiotics for comparison.

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 ID:

2026-526149-91-00

Protocol code:

ZKSJ0165

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?