Trial Outcomes & Findings for DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia (NCT NCT04775953)
NCT ID: NCT04775953
Last Updated: 2024-12-10
Results Overview
DOOR is a composite endpoint assessed by: (1) Clinical Failure: Lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment; (2) Infectious Complications such as: Endocarditis, New evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response; (3) Serious Adverse Events (SAEs); (4) Adverse Events (AEs) Leading to Study Drug Discontinuation; and (5) Death. Clinical failure and infectious complications were assessed by a blinded adjudication committee. Participants missing clinical failure were treated as having clinical failure for calculation of DOOR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Day 70
Results posted on
2024-12-10
Participant Flow
Participants were recruited from 23 clinical sites within the United States and Canada. The first participant was enrolled on April 22, 2021, and the last participant was enrolled on July 6, 2023.
Participant milestones
| Measure |
Dalbavancin
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
84
|
81
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Dalbavancin
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
|
Overall Study
Death
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Participant non-compliance
|
0
|
1
|
Baseline Characteristics
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
Baseline characteristics by cohort
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
100 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Baseline Pathogen
MRSA
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Baseline Pathogen
MSSA
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.83 kg/m^2
STANDARD_DEVIATION 6.91 • n=5 Participants
|
29.03 kg/m^2
STANDARD_DEVIATION 8.08 • n=7 Participants
|
28.93 kg/m^2
STANDARD_DEVIATION 7.50 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 70Population: The intent-to-treat (ITT) population includes all randomized participants.
DOOR is a composite endpoint assessed by: (1) Clinical Failure: Lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment; (2) Infectious Complications such as: Endocarditis, New evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response; (3) Serious Adverse Events (SAEs); (4) Adverse Events (AEs) Leading to Study Drug Discontinuation; and (5) Death. Clinical failure and infectious complications were assessed by a blinded adjudication committee. Participants missing clinical failure were treated as having clinical failure for calculation of DOOR.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Desirability of Outcome Ranking (DOOR)
Rank 3: Alive with two of clinical failure, infectious comp, or SAE or AE leading to trt discont
|
9 Participants
|
7 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Rank 4: Alive with all of clinical failure, infectious comp, and SAE or AE leading to trt discont
|
4 Participants
|
3 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Rank 1: Alive with none of clinical failure, infectious comp, or SAE or AE leading to trt discont
|
49 Participants
|
49 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Rank 2: Alive with one of clinical failure, infectious comp, or SAE or AE leading to trt discont
|
34 Participants
|
37 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Rank 5: Death
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 70Population: The modified intent-to-treat (mITT) population includes all randomized participants who received at least one dose of study drug.
Number of participants that had clinical efficacy at Day 70. Clinical efficacy is defined as none of: (1) Clinical Failure: Lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment; (2) Infectious Complications such as: Endocarditis, New evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response; and (3) Death. Clinical failure and infectious complications are assessed by a blinded adjudication committee. Participants missing clinical failure are treated as not having clinical efficacy.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of Clinical Efficacy
|
73 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 180Population: The mITT population includes all randomized participants who received at least one dose of study drug.
Number of participants that experience any SAEs from Day 1 to study completion (Day 70 or Day 180 for participants in the osteomyelitis subset). An AE is considered serious if, in the view of either the site principal investigator or sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of SAEs
|
43 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 180Population: The mITT population includes all randomized participants who received at least one dose of study drug.
Number of participants that experience any AEs leading to study drug discontinuation from Day 1 to study completion (Day 70 or Day 180 for participants in the osteomyelitis subset).
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of AEs Leading to Study Drug Discontinuation
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 70Population: The ITT population includes all randomized participants.
Number of participants who had clinical failure at Day 70, used for DOOR at Day 70. Clinical Failure is defined as lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment. Clinical failure is assessed by a blinded adjudication committee. Participants missing clinical failure are treated as having clinical failure.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of Clinical Failure (A Component of DOOR)
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 70Population: The ITT population includes all randomized participants.
Number of participants that experience any infectious complications from Day 1 through Day 70, used for DOOR at Day 70. Infectious complications include endocarditis, new evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response. Infectious complications are assessed by a blinded adjudication committee.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of Infectious Complications (A Component of DOOR)
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 70Population: The ITT population includes all randomized participants.
Number of participants that experience any SAEs from Day 1 to Day 70, used for DOOR at Day 70. An AE is considered serious if, in the view of either the site principal investigator or sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of SAEs (A Component of DOOR)
|
40 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 70Population: The ITT population includes all randomized participants.
Number of participants that experience any AEs leading to study drug discontinuation from Day 1 to Day 70, used for DOOR at Day 70.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of AEs Leading to Study Drug Discontinuation (A Component of DOOR)
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 70Population: The ITT population includes all randomized participants.
Number of participants who passed away from Day 1 to Day 70, used for DOOR at Day 70.
Outcome measures
| Measure |
Dalbavancin
n=100 Participants
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 Participants
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Frequency of All-Cause Mortality (A Component of DOOR)
|
4 Participants
|
4 Participants
|
Adverse Events
Dalbavancin
Serious events: 43 serious events
Other events: 5 other events
Deaths: 5 deaths
Standard of Care
Serious events: 37 serious events
Other events: 1 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dalbavancin
n=100 participants at risk
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 participants at risk
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Blood and lymphatic system disorders
Cytopenia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
1.0%
1/100 • Number of events 3 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Cardiac failure chronic
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
General disorders
Death
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
General disorders
Chest pain
|
1.0%
1/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
General disorders
Complication associated with device
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
General disorders
Drug withdrawal syndrome
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
General disorders
Pyrexia
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Sepsis
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Abscess
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Arthritis bacterial
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Bacteraemia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Bacteriuria
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
COVID-19
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Cellulitis
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Diabetic foot infection
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Extradural abscess
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Infection
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Intervertebral discitis
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Osteomyelitis
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
5.0%
5/100 • Number of events 5 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Osteomyelitis acute
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/100 • Number of events 3 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
3.0%
3/100 • Number of events 3 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Pneumonia aspiration
|
1.0%
1/100 • Number of events 3 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Pneumonia bacterial
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Prostate infection
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Proteus infection
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Septic pulmonary embolism
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Septic shock
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Splenic abscess
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
3.0%
3/100 • Number of events 3 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Staphylococcal infection
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
4.0%
4/100 • Number of events 4 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Renal and urinary disorders
Renal colic
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
1/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
3/100 • Number of events 3 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Gastrointestinal disorders
Varices oesophageal
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/100 • Number of events 4 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/100 • Number of events 2 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Nervous system disorders
Headache
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Nervous system disorders
Intracranial mass
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Psychiatric disorders
Confusional state
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Psychiatric disorders
Delirium
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Psychiatric disorders
Major depression
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Vascular disorders
Acute myocardial infarction
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
|
Vascular disorders
Subclavian artery aneurysm
|
0.00%
0/100 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
Other adverse events
| Measure |
Dalbavancin
n=100 participants at risk
Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.
Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
|
Standard of Care
n=100 participants at risk
For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).
For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).
Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.
Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.
Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.
Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.
Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis.
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
5/100 • Number of events 5 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
1.0%
1/100 • Number of events 1 • All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place