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
| Registry | NCT03148756 |
|---|
| Status | Terminated - Study stopped due to business reasons. |
|---|
| Phase | Phase 2 |
|---|
| Study type | Interventional; randomized, parallel, masking: single, treatment |
|---|
| Enrollment | 2 (Actual) |
|---|
| Sponsor | AbbVie (Industry) |
|---|
| Conditions | Endocarditis, Bacteremia |
|---|
| Interventions | Dalbavancin, Standard of Care (Drug) |
|---|
| Dates | start 2017-05-12, primary completion 2017-08-04, completion 2017-08-04, first posted 2017-05-11, last updated 2022-04-25 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Endocarditis All trials for Bacteremia All trials of Dalbavancin All trials of Standard of Care
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Dalbavancin | Experimental | Drug: Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. |
| Standard of Care | Active comparator | Drug: Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
- Dalbavancin (Drug): Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
- Standard of Care (Drug): Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
+Outcome measures
Primary outcomes
- Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population [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.
Secondary outcomes
- Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population [Day 42]: 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.
- Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population [Day 42]: 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.
- Number of Participants With Day 84 Mortality in the Safety Population [Day 84]: Day 84 mortality was measured by the number of deaths up to Day 84.
- Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population [Day 84]: 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.
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population [Day 42]: 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.
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population [Day 84]: 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.
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population [Day 42]: 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.
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population [Day 84]: 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.
- Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population [Day 42]: Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
- Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population [Day 84]: Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
- Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population [Day 42]: Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
- Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population [Day 84]: Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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.
+Posted results
Participant flow
| Milestone | Dalbavancin | Standard of Care |
|---|
| Started | 0 | 2 |
| Completed | 0 | 1 |
| Not completed | 0 | 1 |
Outcome results
- Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population (Primary), Count of participants, Participants: Dalbavancin ; Standard of Care 1
- Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Number of Participants With Day 84 Mortality in the Safety Population (Secondary), Count of participants, Participants: Dalbavancin ; Standard of Care 0
- Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
- Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population (Secondary), Number, percentage of participants: Dalbavancin ; Standard of Care 100
Adverse events
Time frame: Up to 84 Days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Dalbavancin | 0 | 0 | 0 |
| Standard of Care | 0/2 (0.0%) | 0 | 1/2 (50.0%) |
Other adverse events by term
| Term | Organ system | Dalbavancin | Standard of Care |
|---|
| Anaemia | Blood and lymphatic system disorders | 0/0 | 1/2 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Midway Immunology and Research Center | Ft. Pierce, Florida | United States | |
+Study documents
+Investigators