Trial Outcomes & Findings for Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis (NCT NCT02685033)
NCT ID: NCT02685033
Last Updated: 2019-01-04
Results Overview
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
COMPLETED
PHASE2
80 participants
Day 42
2019-01-04
Participant Flow
Participant milestones
| Measure |
Dalbavancin
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
10
|
|
Overall Study
COMPLETED
|
67
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Dalbavancin
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal of Consent
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
Baseline characteristics by cohort
| Measure |
Dalbavancin
n=70 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=10 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
70 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42Population: CE-D42 population included all modified intent-to-treat (mITT) participants who met specific conditions for evaluability at Day 42 (D42).
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=67 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Clinical Cure
|
97.0 percentage of participants
Interval 89.6 to 99.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Clinical Failure
|
0.0 percentage of participants
As per protocol, 95% Confidence Interval (CI) was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Indeterminate
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
PRIMARY outcome
Timeframe: Day 365Population: CE-D365 population included all mITT participants who met specific conditions for evaluability at Day 365 (D365).
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=66 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Day 365 in the CE Population
Clinical Cure
|
95.5 percentage of participants
Interval 87.3 to 99.1
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Clinical Response at Day 365 in the CE Population
Clinical Failure
|
1.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participants With Clinical Response at Day 365 in the CE Population
Indeterminate
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
SECONDARY outcome
Timeframe: Baseline to Day 21Population: mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.
Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein \[CRP\]).
Outcome measures
| Measure |
Dalbavancin
n=67 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population
|
94.0 percentage of participants
Interval 85.4 to 98.3
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
SECONDARY outcome
Timeframe: Baseline to Day 21Population: CE-D21 population included all mITT (modified intent-to-treat) participants who met specific conditions for evaluability at Day 21 (D21).
Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein \[CRP\]).
Outcome measures
| Measure |
Dalbavancin
n=67 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Improvement at Day 21 in the CE Population
|
94.0 percentage of participants
Interval 85.4 to 98.3
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
SECONDARY outcome
Timeframe: Day 42Population: mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=67 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Day 42 in the mITT Population
Clinical Cure
|
97.0 percentage of participants
Interval 89.6 to 99.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Clinical Response at Day 42 in the mITT Population
Clinical Failure
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participants With Clinical Response at Day 42 in the mITT Population
Indeterminate
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
SECONDARY outcome
Timeframe: Day 42Population: Micro-mITT population included mITT participants with a Gram-positive pathogen isolated from blood and/or bone specimen. Participants whose cultures included both a Gram-positive and a Gram-negative pathogen are included.
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=62 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
Clinical Cure
|
96.8 percentage of participants
Interval 88.8 to 99.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
Clinical Failure
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
Indeterminate
|
3.2 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
SECONDARY outcome
Timeframe: Day 180Population: mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=67 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participant With Clinical Response at Day 180 in the mITT Population
Clinical Cure
|
94.0 percentage of participants
Interval 85.4 to 98.3
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participant With Clinical Response at Day 180 in the mITT Population
Clinical Failure
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participant With Clinical Response at Day 180 in the mITT Population
Indeterminate
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
SECONDARY outcome
Timeframe: Day 180Population: CE-D180 population included all mITT participants who met specific conditions for evaluability at Day 180 (D180).
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=66 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Day 180 in the CE Population
Clinical Cure
|
95.5 percentage of participants
Interval 87.3 to 99.1
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Clinical Response at Day 180 in the CE Population
Clinical Failure
|
1.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participants With Clinical Response at Day 180 in the CE Population
Indeterminate
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
SECONDARY outcome
Timeframe: Day 365Population: mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=67 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Day 365 in the mITT Population
Clinical Cure
|
94.0 percentage of participants
Interval 85.4 to 98.3
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With Clinical Response at Day 365 in the mITT Population
Clinical Failure
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
|
Percentage of Participants With Clinical Response at Day 365 in the mITT Population
Indeterminate
|
3.0 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
12.5 percentage of participants
As per protocol, 95% CI was only calculated for outcome of clinical cure.
|
SECONDARY outcome
Timeframe: Day 42Population: CE-D42 population included all mITT participants who met specific conditions for evaluability at Day 42 (D42). Includes participants who had baseline pathogens. Participants who had more than one pathogen at Baseline were counted in each category.
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=62 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Prevotella intermedia
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Prevotella species
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Staphylococcus aureus
|
41 participants
|
5 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Staphylococcus epidermidis
|
6 participants
|
2 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Staphylococcus haemolyticus
|
3 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Staphylococcus pasteuri
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Staphylococcus hominis
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Staphylococcus simulans
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Enterococcus faecalis
|
7 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Enterococcus faecium
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Streptococcus agalactiae
|
1 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Streptococcus dysgalactiae
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Streptococcus pyogenes
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Corynebacterium striatum
|
2 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Aerococcus viridans
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Globicatella species
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Micrococcus luteus
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Peptoniphilus harei
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Anaerococcus prevotii
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Finegoldia magna
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Peptostrep. anaerobius
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Escherichia coli
|
3 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Klebsiella pneumoniae
|
2 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Pseudomonas aeruginosa
|
2 participants
|
0 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Enterobacter cloacae complex
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Morganella morganii
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Proteus mirabilis
|
1 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Raoultella planticola
|
1 participants
|
0 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Serratia marcescens
|
—
|
0 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Escherichia hermannii
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Pluralibacter gergoviae
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Acinetobacter calcoaceticus
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Bacteroides fragilis
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Bacteroides thetaiotaomicron
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Bacteroides vulgatus
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Porphyromonas asaccharolytica
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Prevotella melaninogenica
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Prevotella disiens
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 180Population: CE-D180 population included all mITT participants who met specific conditions for evaluability at Day 180 (D180). Includes participants who had baseline pathogens. Participants who had more than one pathogen at Baseline were counted in each category.
Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).
Outcome measures
| Measure |
Dalbavancin
n=61 Participants
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=8 Participants
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Staphylococcus aureus
|
39 participants
|
5 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Staphylococcus epidermidis
|
6 participants
|
2 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Staphylococcus haemolyticus
|
3 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Staphylococcus pasteuri
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Staphylococcus hominis
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Staphylococcus simulans
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Enterococcus faecalis
|
7 participants
|
0 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Enterococcus faecium
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Streptococcus agalactiae
|
1 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Streptococcus dysgalactiae
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Streptococcus pyogenes
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Corynebacterium striatum
|
2 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Aerococcus viridans
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Globicatella species
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Micrococcus luteus
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Peptoniphilus harei
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Anaerococcus prevotii
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Finegoldia magna
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Peptostrep. anaerobius
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Escherichia coli
|
3 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Klebsiella pneumoniae
|
2 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Pseudomonas aeruginosa
|
2 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Enterobacter cloacae complex
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Morganella morganii
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Proteus mirabilis
|
1 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Raoultella planticola
|
1 participants
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Serratia marcescens
|
—
|
1 participants
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Escherichia hermannii
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Pluralibacter gergoviae
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Acinetobacter calcoaceticus
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Bacteroides fragilis
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Bacteroides thetaiotaomicron
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Bacteroides vulgatus
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Porphyromonas asaccharolytica
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Prevotella melaninogenica
|
2 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Prevotella disiens
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Prevotella intermedia
|
1 participants
|
—
|
|
Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Prevotella species
|
1 participants
|
—
|
Adverse Events
Dalbavancin
Standard of Care
Serious adverse events
| Measure |
Dalbavancin
n=70 participants at risk
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and Day 8. If creatinine clearance was \< 30 milliliters per minute (mL/min) and participant was not receiving regular hemodialysis or peritoneal dialysis, dalbavancin dose was decreased to 1000 mg.
|
Standard of Care
n=10 participants at risk
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
1.4%
1/70 • Number of events 1 • From Baseline (Day 0) to Day 365
|
0.00%
0/10 • From Baseline (Day 0) to Day 365
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
1.4%
1/70 • Number of events 1 • From Baseline (Day 0) to Day 365
|
0.00%
0/10 • From Baseline (Day 0) to Day 365
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees that the first results publication shall be made in conjunction with a joint multi-center publication. If the multi-center publication is not submitted within 12 months after conclusion of the study at all sites, or if the sponsor confirms not to publish the results, the PI may publish the results from the institution subject to terms of the clinical trial agreement. The publication must be sent to Sponsor at least 60 days before the intended submission date for reference and comment.
- Publication restrictions are in place
Restriction type: OTHER