EndocarditisPhase 2NCT03148756
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
A Phase 2 study testing Dalbavancin in people with Endocarditis and Bacteremia, run by AbbVie at 1 site in United States.
Trial summary
This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Bacteremia
- What is being tested?
- Dalbavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to 4 Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A diagnosis of complicated bacteremia or infective endocarditis
- Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci
- Treatment with standard of care antibiotics for 72 hours (h) - 10 days
- Defervescence for at least 24h and clearance of bacteremia from screening pathogen.
Who cannot join
- Embolic events
- History of prosthetic valve surgery, cardiac device or prosthetic joint
- Left-sided endocarditis due to Staphylococcus aureus (S. aureus)
- Large mobile vegetations (>10 mm) on mitral valves
- Perivalvular abscess
- Uncomplicated bacteremia due to S. aureus
Show all 17Show fewer
- Gram-negative bacteria or fungi in blood cultures
- Heart failure associated with infective endocarditis [Left Ventricular Ejection Fraction (LVEF) <40%]
- Intravascular material or removable infection source not intended to be removed within 4 days postrandomization
- Planned valve replacement surgery within 3 days of randomization
- Refractory shock, significant hepatic insufficiency or severe leukopenia [Absolute Neutrophil Count (ANC) < 500 cells/mm^3]
- Known osteomyelitis
- Hypersensitivity to dalbavancin or other drugs in glycopeptide class
- Infection with enterococci, coagulase-negative staphylococci, or with organism not susceptible to dalbavancin or vancomycin
- Immunosuppression/immune deficiency
- Concomitant systemic antibacterial therapy for gram-positive infection other than that allowed in protocol
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
About this study
Official title: Phase 2, Open-Label, Randomized, Multicenter Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Documented Infective Endocarditis
This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.
- Conditions
- Endocarditis, Bacteremia
- Being tested
- Dalbavancin, Standard of Care
- Medical subject headings
- Endocarditis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Standard of CareDrug
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Experimental | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. Receives: Drug: Dalbavancin |
| Standard of Care | Active comparator | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.
Measured: Day 84
Secondary outcomes (12)
Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population
Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 42
Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population
Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 42
Number of Participants With Day 84 Mortality in the Safety Population
Day 84 mortality was measured by the number of deaths up to Day 84.
Measured: Day 84
Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population
Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 84
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population
Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 42
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population
Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 84
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population
Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 42
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population
Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
Measured: Day 84
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Measured: Day 42
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Measured: Day 84
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Measured: Day 42
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start12 May 2017
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
Why it stopped: Study stopped due to business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urania Rappo, MD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148756
- Sponsor's protocol ID
- DAL-MD-09
- Status last verified
- Mar 2022
- First submitted
- 9 May 2017
- Last updated
- 25 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-Label, Randomized, Multicenter Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Documented Infective Endocarditis
- ClinicalTrials.gov ID
- NCT03148756
- Acronym / sponsor ID
- DAL-MD-09
- Conditions
- Endocarditis, Bacteremia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to business reasons.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 12 May 2017 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | Experimental | Drug: DalbavancinDalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. |
| Standard of Care | Active comparator | Drug: Standard of CareAntibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of complicated bacteremia or infective endocarditis
- Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci
- Treatment with standard of care antibiotics for 72 hours (h) - 10 days
- Defervescence for at least 24h and clearance of bacteremia from screening pathogen.
Key exclusion criteria (17 listed)
- Embolic events
- History of prosthetic valve surgery, cardiac device or prosthetic joint
- Left-sided endocarditis due to Staphylococcus aureus (S. aureus)
- Large mobile vegetations (>10 mm) on mitral valves
- Perivalvular abscess
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 |
|---|---|---|
| DalbavancinDalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | Drug | Dalbavancin |
| Standard of CareAntibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. | Drug | Standard of Care |
Primary outcome
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
Time frame: Day 84
Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.
12 secondary outcomes
Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population
Time frame: Day 42
Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population
Time frame: Day 42
Number of Participants With Day 84 Mortality in the Safety Population
Time frame: Day 84
Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population
Time frame: Day 84
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population
Time frame: Day 42
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population
Time frame: Day 84
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population
Time frame: Day 42
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population
Time frame: Day 84
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population
Time frame: Day 42
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population
Time frame: Day 84
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population
Time frame: Day 42
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population
Time frame: Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Urania Rappo, MD study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalbavancin in people with Endocarditis and Bacteremia, run by AbbVie at 1 site in United States.
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 4 inclusion and 17 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: stopped early, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population (time frame: Day 84). 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 25 Apr 2022.