Endocarditis InfectivePhase 3EndoDalbaNCT07699211
Dalbavancin Therapy for Infective Endocarditis
A Phase 3 study testing Dalbavancin administration in people with Endocarditis Infective and Endocarditis, Bacterial, run by Stefan Hagel at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis Infective, Endocarditis, Bacterial
- What is being tested?
- Dalbavancin administration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 9 sitesGermany
- Study dates
- Dec 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Germany9 sites
Vivantes Auguste-Viktoria-Klinikum
Berlin, State of Berlin, 12157
Daniela Tominski, Dr., +49130202321, daniela.tominski@vivantes.de
Deutsches Herzzentrum der Charité (DHZC)
Berlin, State of Berlin, 13353
Miriam Stegemann, Dr., +4930450665037, miriam.stegemann@charite.de
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Norma Jung, Prof. Dr., +4922147886711, norma.jung@uk-koeln.de
Helios Klinikum Erfurt GmbH
Erfurt, Thuringia, 99089
Alexander Lauten, Prof. Dr., +493617812481, Alexander.Lauten@helios-gesundheit.de
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Siegbert Richard Sieg, Prof. Dr., +4976127018190, siegbert.rieg@uniklinik-freiburg.de
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Stefan Schmiedel, Dr., +4940741028532, s.schmiedel@uke.de
University Hospital Jena
Jena, Thuringia, 07747
Stefan Hagel, PD Dr., +4936419324590, stefan.hagel@med.uni-jena.de
Klinikum St. Gerog gGmbh
Leipzig, Saxony, 04129
Christoph Lübbert, Prof. Dr., +493419092601, Christoph.Luebbert@medizin.uni-leipzig.de
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
Frank Hanses, Prof. Dr., +4994414251, frank.hanses@klinik.uni-regensburg.de
About this study
Official title: 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.
- Conditions
- Endocarditis Infective, Endocarditis, Bacterial
- Being tested
- Dalbavancin administration, Standard of Care (Investigator Choice)
- Keywords
- Infective Endocarditis, Dalbavancin
- Medical subject headings
- Endocarditis, Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalbavancin administrationDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Dalbavancin 500 mg; intravenous, 30-minute infusion duration per administration Receives: 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 Receives: Drug: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 90
Secondary outcomes (16)
Length of hospital stay (days)
Measured: Day 90
National Institutes of Health Stroke Scale (NIHSS)
Scores range from 0 to 42, where 0 indicates normal function and higher numbers reflect greater impairment
Measured: Day 90 and 1 year
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").
Measured: Day 90 and 1 year
Overall mortality
Measured: Day 90 and 1 year
Cardiac surgery
Measured: Day 90 and 1 year
Infectious complications
Measured: Day 90 and 1 year
Embolic event
Measured: Day 90 and 1 year
Clinical Frailty Scale
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).
Measured: Day 90 and 1 year
Occurrence of treatment-related adverse events
Measured: Baseline to End of Therapy +14 days
Dalbavancin Plasma Concentration
Through level, mg/l
Measured: Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35
Microbiome analysis
Shannon Diversity Index, 1-5 range, Generally, a higher score indicates a BETTER outcome
Measured: Baseline, Day 90 and 1 year
Cost of antibiotic therapy
Measured: Day 90
Number of days of work disability
Measured: Day 90
modified Rankin Scale (mRS)
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)
Measured: Day 90 and 1 year
EQ-5D-5L index
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.
Measured: Day 90 and 1 year
Reintegration to Normal Living Index (RNLI)
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
Measured: Day 90 and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis InfectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Hagel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Hagel, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699211
- Sponsor's protocol ID
- ZKSJ0165
- Other IDs
- 2026-526149-91-00
- Acronym
- EndoDalba
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dalbavancin in the Treatment of Infective Endocarditis Caused by Gram-Positive Cocci
- ClinicalTrials.gov ID
- NCT07699211
- Acronym / sponsor ID
- EndoDalba / ZKSJ0165
- Conditions
- Endocarditis Infective, Endocarditis, Bacterial
- Keywords
- Infective Endocarditis, Dalbavancin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Stefan HagelUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: Dalbavancin administrationDalbavancin 500 mg; intravenous, 30-minute infusion duration per administration |
| control group | Other | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalbavancin administrationDosage: 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) | Drug | intervention group |
| 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) | Drug | control group |
Primary outcome
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
16 secondary outcomes
Length of hospital stay (days)
Time frame: Day 90
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Day 90 and 1 year
PROMIS-29 domain-specific T-scores and pain intensity
Time frame: Day 90 and 1 year
Overall mortality
Time frame: Day 90 and 1 year
Cardiac surgery
Time frame: Day 90 and 1 year
Infectious complications
Time frame: Day 90 and 1 year
Embolic event
Time frame: Day 90 and 1 year
Clinical Frailty Scale
Time frame: Day 90 and 1 year
Occurrence of treatment-related adverse events
Time frame: Baseline to End of Therapy +14 days
Dalbavancin Plasma Concentration
Time frame: Day 1, Day 2, Day 14, and if applicable, Day 2, Day 28, Day 35
Microbiome analysis
Time frame: Baseline, Day 90 and 1 year
Cost of antibiotic therapy
Time frame: Day 90
Number of days of work disability
Time frame: Day 90
modified Rankin Scale (mRS)
Time frame: Day 90 and 1 year
EQ-5D-5L index
Time frame: Day 90 and 1 year
Reintegration to Normal Living Index (RNLI)
Time frame: Day 90 and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalbavancin administration in people with Endocarditis Infective and Endocarditis, Bacterial, run by Stefan Hagel at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Hagel, PD Dr. (+4936419324590, stefan.hagel@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.