Dalbavancin Therapy for Infective Endocarditis

NCT07699211 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: ZKSJ01652026-526149-91-00
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Endocarditis Infective; Endocarditis, Bacterial

Keywords

Infective Endocarditis; Dalbavancin

Outcome Measures

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

  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

Secondary Outcomes (16)

• Length of hospital stay (days)

  Day 90

• National Institutes of Health Stroke Scale (NIHSS)

  Day 90 and 1 year

• PROMIS-29 domain-specific T-scores and pain intensity

  Day 90 and 1 year

• Overall mortality

  Day 90 and 1 year

• Cardiac surgery

  Day 90 and 1 year

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Dalbavancin 500 mg; intravenous, 30-minute infusion duration per administration

Drug: Dalbavancin administration

control group

OTHER

Therapy in accordance with the recommendations of the current European Society of Cardiology (ESC) guidelines for the treatment of endocarditis, including oral sequential therapy

Drug: Standard of Care (Investigator Choice)

Interventions

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)

intervention group

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)

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefan Hagel: lead

Study Sites (9)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

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

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Klinikum St. Gerog gGmbh

Leipzig, Saxony, 04129, Germany

Location

Vivantes Auguste-Viktoria-Klinikum

Berlin, State of Berlin, 12157, Germany

Location

Deutsches Herzzentrum der Charité (DHZC)

Berlin, State of Berlin, 13353, Germany

Location

Helios Klinikum Erfurt GmbH

Erfurt, Thuringia, 99089, Germany

Location

University Hospital Jena

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Endocarditis; Endocarditis, Bacterial

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Stefan Hagel, PD Dr.

CONTACT

+4936419324590; stefan.hagel@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsorbevollmächtigter

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

DE (9)