A Phase 2 interventional study of Dalbavancin and Standard of Care in Endocarditis and Bacteremia, sponsored by AbbVie. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Drug: Dalbavancin
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Drug: Standard of Care
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.
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.
Time frame: Day 84
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 84
| Milestone | Dalbavancin | Standard of Care |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 1 |
| Not completed | 0 | 1 |
| Withdrew: Study terminated | 0 | 1 |
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.
| Participants | Dalbavancin | Standard of Care |
|---|---|---|
| Success | — | 1 |
| Failure | — | 0 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population | — | 100 |
Day 84 mortality was measured by the number of deaths up to Day 84.
| Participants | Dalbavancin | Standard of Care |
|---|---|---|
| Number of Participants With Day 84 Mortality in the Safety Population | — | 0 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population | — | 100 |
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 | Dalbavancin | Standard of Care |
|---|---|---|
| Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population | — | 100 |
Collected over Up to 84 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dalbavancin | — | — | — |
| Standard of Care | 0/2 (0%) | — | 1/2 (50%) |
| Event | Dalbavancin | Standard of Care |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | — | 1/2 |
All randomized participants.
| Age, Categorical(Participants) | Dalbavancin | Standard of Care | Total |
|---|---|---|---|
| <=18 years | — | — | 0 |
| Between 18 and 65 years | — | — | 0 |
| >=65 years | — | — | 0 |
| Sex: Female, Male(Participants) | Dalbavancin | Standard of Care | Total |
|---|---|---|---|
| Female | — | — | 0 |
| Male | — | — | 0 |
| Race/Ethnicity, Customized(Participants) | Dalbavancin | Standard of Care | Total |
|---|---|---|---|
| White | 0 | 2 | 2 |
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