| Primary | 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. | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Count of Participants | | Participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
| | | Title | Denominators | Categories |
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| Success | | | | Failure | | |
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| Secondary | 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. | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Number | | percentage of participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | Posted | | Number | | percentage of participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | Safety Population included all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Count of Participants | | Participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Number | | percentage of participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | Posted | | Number | | percentage of participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Number | | percentage of participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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| Secondary | 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. | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | Posted | | Number | | percentage of participants | | Day 42 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
| |
| Secondary | 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. | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | Posted | | Number | | percentage of participants | | Day 84 | | | | ID | Title | Description |
|---|
| OG000 | Dalbavancin | Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. | | OG001 | Standard of Care | Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. |
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