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NCT Number: NCT07699211

Dalbavancin Therapy for Infective Endocarditis

This study compares two treatment strategies for antibiotic therapy in endocarditis. The aim of the study is to determine which treatment is more effective overall and better tolerated by patients.

The first strategy is standard therapy: treatment with proven antibiotics, which are usually administered initially as an intravenous infusion in the hospital and can be switched to oral therapy with tablets later on for suitable patients.

The second strategy is the study treatment with dalbavancin: This is a long-acting antibiotic. It is administered as a single infusion; for longer treatment durations, a second infusion may be necessary 14 days later.

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Key information

Conditions

Endocarditis Infective Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Cardiovascular Infections Endocarditis Endocarditis, Bacterial Heart Diseases Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinikum Freiburg, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • written informed consent
  • 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

  • Hemodynamic instability requiring vasopressor therapy within the last 72 hours prior to randomization
  • 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
  • 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:
  • Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 mIU/mL)
  • Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy)
  • 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)
  • sexual abstinence
  • Vasectomy of the partner

Treatment and study plan

Dalbavancin administration

Drug

Dosage: Total dose depending on the required duration of therapy for endocarditis Route of administration: intravenous, 30-minute infusion duration per administration Frequency: Day 0 and, if necessary, an additional administration on Day 14 ± 2 days, depending on the required duration of therapy for endocarditis Duration of treatment: depending on the required duration of therapy for endocarditis (2-5 weeks)

Standard of Care (Investigator Choice)

Drug

Therapy in accordance with the recommendations of the current European Society of Cardiology (ESC) guidelines for the treatment of endocarditis, including oral sequential therapy Test drug: depending on pathogen, resistance, and comorbidities Dosage: depending on pathogen, resistance, and comorbidities Route of administration: intravenous, including oral sequential therapy Duration of treatment: depending on the required treatment duration for endocarditis (2-5 weeks)

Primary outcomes

  1. Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy

    Time frame: Day 90

    Five possible DOOR ratings are distinguished:

    • Alive, no events
    • Alive, one event
    • Alive, two events
    • Alive, three events
    • Death within 90 days

    Door events include:

    • Cardiac surgery
    • Infectious complication
    • Embolic event

Secondary outcomes

  1. Length of hospital stay (days)

    Time frame: Day 90

  2. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Day 90 and 1 year

    Scores range from 0 to 42, where 0 indicates normal function and higher numbers reflect greater impairment

  3. PROMIS-29 domain-specific T-scores and pain intensity

    Time frame: Day 90 and 1 year

    The PROMIS-29 assesses physical, mental, and social health using 7 domains (4 items each) and pain intensity (1 item). A higher Domain-Specific T-Score (scale range 20-80) means a better outcome for functional domains (Physical Function, Social Roles) but a worse outcome for symptom domains (Anxiety, Depression, Fatigue, Sleep Disturbance). Pain intensity is recorded on an 11-point numeric scale (0-10, where 0 is "no pain" and 10 is "worst imaginable").

  4. Overall mortality

    Time frame: Day 90 and 1 year

  5. Cardiac surgery

    Time frame: Day 90 and 1 year

  6. Infectious complications

    Time frame: Day 90 and 1 year

  7. Embolic event

    Time frame: Day 90 and 1 year

  8. Clinical Frailty Scale

    Time frame: Day 90 and 1 year

    The Clinical Frailty Scale (CFS) ranges from a minimum of 1 (representing "very fit") to a maximum of 9 (representing "terminally ill"), meaning a higher score indicates a WORSE outcome (reflecting a higher level of frailty).

  9. Occurrence of treatment-related adverse events

    Time frame: Baseline to End of Therapy +14 days

  10. Dalbavancin Plasma Concentration

    Time frame: Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35

    Through level, mg/l

  11. Microbiome analysis

    Time frame: Baseline, Day 90 and 1 year

    Shannon Diversity Index, 1-5 range, Generally, a higher score indicates a BETTER outcome

  12. Cost of antibiotic therapy

    Time frame: Day 90

  13. Number of days of work disability

    Time frame: Day 90

  14. modified Rankin Scale (mRS)

    Time frame: Day 90 and 1 year

    7-point clinical scale used to measure the degree of disability or dependence in the daily activities. Scores range from 0 (no symptoms) to 6 (dead)

  15. EQ-5D-5L index

    Time frame: Day 90 and 1 year

    EuroQuality of Life Five Dimensions (EQ-5D-5L), the descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), with five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems.

  16. Reintegration to Normal Living Index (RNLI)

    Time frame: Day 90 and 1 year

    The Reintegration to Normal Living Index (RNLI) Total Adjusted Score ranges from a minimum of 0 to a maximum of 100, meaning a higher score indicates a BETTER outcome (reflecting full or complete reintegration into normal social activities

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Hagel, PD Dr.

CONTACT

[email protected]

+4936419324590

Sponsors and collaborators

Lead sponsor

Stefan Hagel

Other

Registry information

Official study title

Efficacy and Safety of Dalbavancin in the Treatment of Infective Endocarditis Caused by Gram-Positive Cocci

Acronym: EndoDalba

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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