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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 2 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2017 to primary completion in Aug 2017, 2 months.
Results were first posted in Sep 2018, 1 year 1 month after primary completion. A results delay was requested in Aug 2018.
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dalbavancin