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Dalbavancin Therapy for Infective Endocarditis (EndoDalba)

9. juli 2026 opdateret af: Stefan Hagel

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

184

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyskland
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
    • Bavaria
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 20246
        • Universitätsklinikum Hamburg-Eppendorf
        • Kontakt:
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Universitätsklinikum Köln
        • Kontakt:
    • Saxony
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 12157
      • Berlin, State of Berlin, Tyskland, 13353
        • Deutsches Herzzentrum der Charité (DHZC)
        • Kontakt:
    • Thuringia
      • Erfurt, Thuringia, Tyskland, 99089
      • Jena, Thuringia, Tyskland, 07747

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: intervention group
Dalbavancin 500 mg; intravenous, 30-minute infusion duration per administration
Medicin: Dalbavancin administration
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)
Andet: control group
Therapy in accordance with the recommendations of the current European Society of Cardiology (ESC) guidelines for the treatment of endocarditis, including oral sequential therapy
Medicin: Standard of Care (Investigator Choice)
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy
Tidsramme: 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
Day 90

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospital stay (days)
Tidsramme: Day 90
Day 90
National Institutes of Health Stroke Scale (NIHSS)
Tidsramme: Day 90 and 1 year
Scores range from 0 to 42, where 0 indicates normal function and higher numbers reflect greater impairment
Day 90 and 1 year
PROMIS-29 domain-specific T-scores and pain intensity
Tidsramme: 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").
Day 90 and 1 year
Overall mortality
Tidsramme: Day 90 and 1 year
Day 90 and 1 year
Cardiac surgery
Tidsramme: Day 90 and 1 year
Day 90 and 1 year
Infectious complications
Tidsramme: Day 90 and 1 year
Day 90 and 1 year
Embolic event
Tidsramme: Day 90 and 1 year
Day 90 and 1 year
Clinical Frailty Scale
Tidsramme: 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).
Day 90 and 1 year
Occurrence of treatment-related adverse events
Tidsramme: Baseline to End of Therapy +14 days
Baseline to End of Therapy +14 days
Dalbavancin Plasma Concentration
Tidsramme: Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35
Through level, mg/l
Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35
Microbiome analysis
Tidsramme: Baseline, Day 90 and 1 year
Shannon Diversity Index, 1-5 range, Generally, a higher score indicates a BETTER outcome
Baseline, Day 90 and 1 year
Cost of antibiotic therapy
Tidsramme: Day 90
Day 90
Number of days of work disability
Tidsramme: Day 90
Day 90
modified Rankin Scale (mRS)
Tidsramme: 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)
Day 90 and 1 year
EQ-5D-5L index
Tidsramme: 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.
Day 90 and 1 year
Reintegration to Normal Living Index (RNLI)
Tidsramme: 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
Day 90 and 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stefan Hagel

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZKSJ0165
  • 2026-526149-91-00 (Ctis)

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Kliniske forsøg med Endokarditis, bakteriel

Kliniske forsøg med Dalbavancin administration

Søg i lignende forsøg

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