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Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02685033
Recruitment Status : Completed
First Posted : February 18, 2016
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Durata Therapeutics Inc., an affiliate of Allergan plc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteomyelitis
Interventions Drug: Dalbavancin
Drug: Comparator
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description 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. Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Period Title: Overall Study
Started 70 10
Completed 67 8
Not Completed 3 2
Reason Not Completed
Withdrawal of Consent             0             1
Lost to Follow-up             2             1
Adverse Event             1             0
Arm/Group Title Dalbavancin Standard of Care Total
Hide Arm/Group Description 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. Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 70 10 80
Hide Baseline Analysis Population Description
Safety population included all intent-to-treat (ITT) participants who received any amount of randomized medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 10 participants 80 participants
49.2  (13.3) 54.4  (15.3) 49.8  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 10 participants 80 participants
Female
11
  15.7%
5
  50.0%
16
  20.0%
Male
59
  84.3%
5
  50.0%
64
  80.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 10 participants 80 participants
White
70
 100.0%
10
 100.0%
80
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 10 participants 80 participants
Not Hispanic or Latino
70
 100.0%
10
 100.0%
80
 100.0%
1.Primary Outcome
Title Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Hide Description 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).
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
CE-D42 population included all modified intent-to-treat (mITT) participants who met specific conditions for evaluability at Day 42 (D42).
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
97.0
(89.6 to 99.6)
87.5
(47.3 to 99.7)
Clinical Failure
0.0 [1] 
(NA to NA)
12.5 [2] 
(NA to NA)
Indeterminate
3.0 [2] 
(NA to NA)
0.0 [2] 
(NA to NA)
[1]
As per protocol, 95% Confidence Interval (CI) was only calculated for outcome of clinical cure.
[2]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
2.Primary Outcome
Title Percentage of Participants With Clinical Response at Day 365 in the CE Population
Hide Description 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).
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
CE-D365 population included all mITT participants who met specific conditions for evaluability at Day 365 (D365).
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 66 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
95.5
(87.3 to 99.1)
87.5
(47.3 to 99.7)
Clinical Failure
1.5 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Indeterminate
3.0 [1] 
(NA to NA)
12.5 [1] 
(NA to NA)
[1]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
3.Secondary Outcome
Title Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population
Hide Description 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]).
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.0
(85.4 to 98.3)
62.5
(24.5 to 91.5)
4.Secondary Outcome
Title Percentage of Participants With Clinical Improvement at Day 21 in the CE Population
Hide Description 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]).
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
CE-D21 population included all mITT (modified intent-to-treat) participants who met specific conditions for evaluability at Day 21 (D21).
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.0
(85.4 to 98.3)
62.5
(24.5 to 91.5)
5.Secondary Outcome
Title Percentage of Participants With Clinical Response at Day 42 in the mITT Population
Hide Description 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).
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
97.0
(89.6 to 99.6)
87.5
(47.3 to 99.7)
Clinical Failure
0.0 [1] 
(NA to NA)
12.5 [1] 
(NA to NA)
Indeterminate
3.0 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
[1]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
6.Secondary Outcome
Title Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
Hide Description 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).
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 62 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
96.8
(88.8 to 99.6)
87.5
(47.3 to 99.7)
Clinical Failure
0.0 [1] 
(NA to NA)
12.5 [1] 
(NA to NA)
Indeterminate
3.2 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
[1]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
7.Secondary Outcome
Title Percentage of Participant With Clinical Response at Day 180 in the mITT Population
Hide Description 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).
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
94.0
(85.4 to 98.3)
87.5
(47.3 to 99.7)
Clinical Failure
3.0 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
Indeterminate
3.0 [1] 
(NA to NA)
12.5 [1] 
(NA to NA)
[1]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
8.Secondary Outcome
Title Percentage of Participants With Clinical Response at Day 180 in the CE Population
Hide Description 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).
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
CE-D180 population included all mITT participants who met specific conditions for evaluability at Day 180 (D180).
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 66 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
95.5
(87.3 to 99.1)
87.5
(47.3 to 99.7)
Clinical Failure
1.5 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
Indeterminate
3.0 [1] 
(NA to NA)
12.5 [1] 
(NA to NA)
[1]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
9.Secondary Outcome
Title Percentage of Participants With Clinical Response at Day 365 in the mITT Population
Hide Description 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).
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Clinical Cure
94.0
(85.4 to 98.3)
87.5
(47.3 to 99.7)
Clinical Failure
3.0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Indeterminate
3.0 [1] 
(NA to NA)
12.5 [1] 
(NA to NA)
[1]
As per protocol, 95% CI was only calculated for outcome of clinical cure.
10.Secondary Outcome
Title Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population
Hide Description 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).
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 62 8
Measure Type: Number
Unit of Measure: participants
Staphylococcus aureus Number Analyzed 42 participants 6 participants
41 5
Staphylococcus epidermidis Number Analyzed 6 participants 2 participants
6 2
Staphylococcus haemolyticus Number Analyzed 4 participants 0 participants
3
Staphylococcus pasteuri Number Analyzed 1 participants 0 participants
1
Staphylococcus hominis Number Analyzed 2 participants 0 participants
1
Staphylococcus simulans Number Analyzed 1 participants 0 participants
1
Enterococcus faecalis Number Analyzed 7 participants 1 participants
7 1
Enterococcus faecium Number Analyzed 1 participants 0 participants
1
Streptococcus agalactiae Number Analyzed 1 participants 1 participants
1 1
Streptococcus dysgalactiae Number Analyzed 1 participants 0 participants
1
Streptococcus pyogenes Number Analyzed 1 participants 0 participants
1
Corynebacterium striatum Number Analyzed 2 participants 1 participants
2 1
Aerococcus viridans Number Analyzed 1 participants 0 participants
1
Globicatella species Number Analyzed 1 participants 0 participants
1
Micrococcus luteus Number Analyzed 1 participants 0 participants
1
Peptoniphilus harei Number Analyzed 2 participants 0 participants
2
Anaerococcus prevotii Number Analyzed 1 participants 0 participants
1
Finegoldia magna Number Analyzed 1 participants 0 participants
1
Peptostrep. anaerobius Number Analyzed 1 participants 0 participants
1
Escherichia coli Number Analyzed 3 participants 0 participants
3
Klebsiella pneumoniae Number Analyzed 2 participants 1 participants
2 1
Pseudomonas aeruginosa Number Analyzed 2 participants 1 participants
2 0
Enterobacter cloacae complex Number Analyzed 2 participants 0 participants
2
Morganella morganii Number Analyzed 2 participants 0 participants
2
Proteus mirabilis Number Analyzed 1 participants 1 participants
1 1
Raoultella planticola Number Analyzed 1 participants 1 participants
1 0
Serratia marcescens Number Analyzed 0 participants 1 participants
0
Escherichia hermannii Number Analyzed 1 participants 0 participants
1
Pluralibacter gergoviae Number Analyzed 1 participants 0 participants
1
Acinetobacter calcoaceticus Number Analyzed 1 participants 0 participants
1
Bacteroides fragilis Number Analyzed 2 participants 0 participants
2
Bacteroides thetaiotaomicron Number Analyzed 1 participants 0 participants
1
Bacteroides vulgatus Number Analyzed 1 participants 0 participants
1
Porphyromonas asaccharolytica Number Analyzed 2 participants 0 participants
2
Prevotella melaninogenica Number Analyzed 2 participants 0 participants
2
Prevotella disiens Number Analyzed 1 participants 0 participants
1
Prevotella intermedia Number Analyzed 1 participants 0 participants
1
Prevotella species Number Analyzed 1 participants 0 participants
1
11.Secondary Outcome
Title Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population
Hide Description 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).
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
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.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 61 8
Measure Type: Number
Unit of Measure: participants
Staphylococcus aureus Number Analyzed 41 participants 6 participants
39 5
Staphylococcus epidermidis Number Analyzed 6 participants 2 participants
6 2
Staphylococcus haemolyticus Number Analyzed 4 participants 0 participants
3
Staphylococcus pasteuri Number Analyzed 1 participants 0 participants
1
Staphylococcus hominis Number Analyzed 2 participants 0 participants
1
Staphylococcus simulans Number Analyzed 1 participants 0 participants
1
Enterococcus faecalis Number Analyzed 7 participants 1 participants
7 0
Enterococcus faecium Number Analyzed 1 participants 0 participants
1
Streptococcus agalactiae Number Analyzed 1 participants 1 participants
1 1
Streptococcus dysgalactiae Number Analyzed 1 participants 0 participants
1
Streptococcus pyogenes Number Analyzed 1 participants 0 participants
1
Corynebacterium striatum Number Analyzed 2 participants 1 participants
2 1
Aerococcus viridans Number Analyzed 1 participants 0 participants
1
Globicatella species Number Analyzed 1 participants 0 participants
1
Micrococcus luteus Number Analyzed 1 participants 0 participants
1
Peptoniphilus harei Number Analyzed 2 participants 0 participants
2
Anaerococcus prevotii Number Analyzed 1 participants 0 participants
1
Finegoldia magna Number Analyzed 1 participants 0 participants
1
Peptostrep. anaerobius Number Analyzed 1 participants 0 participants
1
Escherichia coli Number Analyzed 3 participants 0 participants
3
Klebsiella pneumoniae Number Analyzed 2 participants 1 participants
2 1
Pseudomonas aeruginosa Number Analyzed 2 participants 1 participants
2 1
Enterobacter cloacae complex Number Analyzed 2 participants 0 participants
2
Morganella morganii Number Analyzed 2 participants 0 participants
2
Proteus mirabilis Number Analyzed 1 participants 1 participants
1 1
Raoultella planticola Number Analyzed 1 participants 1 participants
1 1
Serratia marcescens Number Analyzed 0 participants 1 participants
1
Escherichia hermannii Number Analyzed 1 participants 0 participants
1
Pluralibacter gergoviae Number Analyzed 1 participants 0 participants
1
Acinetobacter calcoaceticus Number Analyzed 1 participants 0 participants
1
Bacteroides fragilis Number Analyzed 2 participants 0 participants
2
Bacteroides thetaiotaomicron Number Analyzed 1 participants 0 participants
1
Bacteroides vulgatus Number Analyzed 1 participants 0 participants
1
Porphyromonas asaccharolytica Number Analyzed 2 participants 0 participants
2
Prevotella melaninogenica Number Analyzed 2 participants 0 participants
2
Prevotella disiens Number Analyzed 1 participants 0 participants
1
Prevotella intermedia Number Analyzed 1 participants 0 participants
1
Prevotella species Number Analyzed 1 participants 0 participants
1
Time Frame From Baseline (Day 0) to Day 365
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description 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. Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
All-Cause Mortality
Dalbavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   1/70 (1.43%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dalbavancin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/70 (2.86%)      0/10 (0.00%)    
Cardiac disorders     
Cardiac failure acute  1  1/70 (1.43%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications     
Inflammation of wound  1  1/70 (1.43%)  1 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dalbavancin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/10 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Durata Therapeutics Inc., an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02685033     History of Changes
Other Study ID Numbers: DAL-MD-04
First Submitted: February 12, 2016
First Posted: February 18, 2016
Results First Submitted: December 11, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019