Back to resultsEfficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
Primary Purpose
Endocarditis, Bacteremia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dalbavancin
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Endocarditis
Eligibility Criteria
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.
Sites / Locations
- Midway Immunology and Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dalbavancin
Standard of Care
Arm Description
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03148756
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to business reasons.
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
August 4, 2017 (Actual)
Study Completion Date
August 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis, Bacteremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalbavancin
Arm Type
Experimental
Arm Description
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Dalbavancin
Intervention Description
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
Description
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.
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population
Description
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.
Time Frame
Day 42
Title
Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population
Description
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.
Time Frame
Day 42
Title
Number of Participants With Day 84 Mortality in the Safety Population
Description
Day 84 mortality was measured by the number of deaths up to Day 84.
Time Frame
Day 84
Title
Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population
Description
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.
Time Frame
Day 84
Title
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population
Description
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.
Time Frame
Day 42
Title
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population
Description
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.
Time Frame
Day 84
Title
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population
Description
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.
Time Frame
Day 42
Title
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population
Description
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.
Time Frame
Day 84
Title
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population
Description
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame
Day 42
Title
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population
Description
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame
Day 84
Title
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population
Description
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame
Day 42
Title
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population
Description
Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame
Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urania Rappo, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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