Health TrialsbyHealthPanel

Dalbavancin Therapy for Infective Endocarditis

ConditionsEndocarditis InfectiveEndocarditis, Bacterial
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStefan Hagel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: intervention groupActive comparator 1 intervention
Group B: control groupOther 1 intervention

Trial outcomes

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

Time frame
Day 90

Secondary outcomes

1

Length of hospital stay (days)

Time frame
Day 90
2

National Institutes of Health Stroke Scale (NIHSS)

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

Time frame
Day 90 and 1 year
3

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

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").

Time frame
Day 90 and 1 year
4

Overall mortality

Time frame
Day 90 and 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stefan Hagel

Lead sponsor

Jena University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: