Trial Outcomes & Findings for Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (NCT NCT02127970)
NCT ID: NCT02127970
Last Updated: 2018-09-28
Results Overview
Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
698 participants
Primary outcome timeframe
Up to 48-72 hours after the initiation of study drug
Results posted on
2018-09-28
Participant Flow
A total of 698 participants were randomly assigned in a 1:1 ratio to the following treatment groups: Single-dose dalbavancin group, received a single dose of dalbavancin intravenous (IV) on Day 1, and a matching placebo IV on Day 8; Two-dose dalbavancin group, received dalbavancin IV on Day 1 and Day 8.
Participant milestones
| Measure |
Single-Dose Dalbavancin
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Overall Study
STARTED
|
349
|
349
|
|
Overall Study
COMPLETED
|
323
|
322
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
Single-Dose Dalbavancin
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
14
|
|
Overall Study
Reason not Specified
|
4
|
7
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Subject Withdrew Consent
|
5
|
3
|
Baseline Characteristics
Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Baseline characteristics by cohort
| Measure |
Single-Dose Dalbavancin
n=349 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=349 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
Total
n=698 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 14.83 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 14.74 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 14.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48-72 hours after the initiation of study drugPopulation: ITT Population included all randomized participants regardless of whether or not they received study drug.
Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=349 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=349 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug
|
81.4 percentage of participants
|
84.2 percentage of participants
|
SECONDARY outcome
Timeframe: End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)Population: ITT Population included all randomized participants regardless of whether or not they received study drug.
Clinical Success is defined as follows: For evaluation at EOT visit, lesion area must be decreased by ≥80% from baseline and at FV lesion area must be decreased by ≥90% from baseline; Temperature is ≤37.6°C; Local signs of tenderness to palpation and swelling/induration are no worse than mild; For evaluation at EOT visit, local signs of fluctuance and localized heat/warmth must be improved from baseline and no worse than mild, and at FV local signs of fluctuance and localized heat/warmth must be absent; for participants with a wound infection the severity of purulent drainage is improved and no worse than mild relative to baseline. Clinical Failure is defined as the opposite to success or if the participant died during the study period up to visit or received study therapy for ABSSSI beyond the protocol treatment period. Clinical status is Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=349 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=349 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
EOT; Clinical Success
|
84.0 percentage of participants
|
84.8 percentage of participants
|
|
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
EOT; Clinical Failure
|
12.0 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
EOT; Indeterminate
|
4.0 percentage of participants
|
4.9 percentage of participants
|
|
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
FV; Clinical Success
|
84.5 percentage of participants
|
85.1 percentage of participants
|
|
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
FV; Clinical Failure
|
8.0 percentage of participants
|
7.2 percentage of participants
|
|
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
FV; Indeterminate
|
7.4 percentage of participants
|
7.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: EOT (Day 14-15)Population: ITT Population included all randomized participants regardless of whether or not they received study drug.
Clinical Success was defined as localized fluctuance and heat/warmth that if present at Baseline must be improved and no worse than mild. Clinical Failure was defined as the opposite to success. Clinical status was Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=349 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=349 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)
Clinical Success
|
84.8 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)
Clinical Failure
|
7.7 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)
Indeterminate
|
7.4 percentage of participants
|
7.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)Population: ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given. An unsuccessful outcome was the opposite of successful. An Indeterminate outcome was defined as any of the data needed to determine a successful or unsuccessful outcome were missing.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=347 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=344 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Unsuccessful Outcome (Day 8)
|
0.6 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Successful Outcome (Day 3-4)
|
93.4 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Unsuccessful Outcome (Day 3-4)
|
0.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Indeterminate (Day 3-4)
|
6.3 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Successful Outcome (Day 8)
|
92.2 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Indeterminate (Day 8)
|
7.2 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Successful Outcome (EOT)
|
92.5 percentage of participants
|
92.7 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Unsuccessful Outcome (EOT)
|
2.9 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Indeterminate (EOT)
|
4.6 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Successful Outcome (Final Visit)
|
90.2 percentage of participants
|
91.0 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Unsuccessful Outcome (Final Visit)
|
2.6 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants by Investigator Assessment of Clinical Outcome
Indeterminate (Final Visit)
|
7.2 percentage of participants
|
7.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3-4 and EOT (Day 14-15)Population: Microbiological Intent-to-treat (MicroITT) Population included all ITT participants who had at least 1 Gram-positive bacterial pathogen isolated at Baseline. Number analyzed is the number of participants with data available for analysis at the given time-point.
A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=210 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=220 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Staphylococcus aureus (Day 3-4)
|
88.5 percentage of participants
|
85.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus agalactiae (Day 3-4)
|
100.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus anginosus group (Day 3-4)
|
93.9 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus dysgalactiae (Day 3-4)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus pyogenes (Day 3-4)
|
100.0 percentage of participants
|
81.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Enterococcus faecalis (Day 3-4)
|
100.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Staphylococcus aureus (EOT)
|
87.8 percentage of participants
|
91.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus agalactiae (EOT)
|
83.3 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus anginosus group (EOT)
|
81.8 percentage of participants
|
89.5 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus dysgalactiae (EOT)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Streptococcus pyogenes (EOT)
|
92.9 percentage of participants
|
81.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Enterococcus faecalis (EOT)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)Population: ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=349 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=349 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants With Complete Resolution of Local Signs of Infection
Day 3-4
|
1.9 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Complete Resolution of Local Signs of Infection
Day 8
|
22.3 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With Complete Resolution of Local Signs of Infection
EOT Visit
|
56.3 percentage of participants
|
56.2 percentage of participants
|
|
Percentage of Participants With Complete Resolution of Local Signs of Infection
Final Visit
|
85.8 percentage of participants
|
89.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days)Population: ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
Using the Brief Pain Inventory Scale, participants rated their pain "right now" on a scale where: 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=349 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=349 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Change From Baseline in Participant's Assessment of Pain
Change from Baseline to Day 8
|
-5.9 Scores on a scale
Standard Deviation 2.53
|
-5.8 Scores on a scale
Standard Deviation 2.68
|
|
Change From Baseline in Participant's Assessment of Pain
Baseline
|
7.7 Scores on a scale
Standard Deviation 2.09
|
7.8 Scores on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Participant's Assessment of Pain
Change from Baseline to Day 3-4
|
-3.9 Scores on a scale
Standard Deviation 2.46
|
-3.8 Scores on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Participant's Assessment of Pain
Change from Baseline to EOT Visit
|
-6.9 Scores on a scale
Standard Deviation 2.37
|
-6.9 Scores on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Participant's Assessment of Pain
Change from Baseline to Final Visit
|
-7.5 Scores on a scale
Standard Deviation 2.19
|
-7.4 Scores on a scale
Standard Deviation 2.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Final Visit (Day 28 +/- 2 days)Population: ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
Resource Utilization Categories included: Any additional visits (including urgent care), Any additional procedures, Any additional tests, Any home visits or nursing care and Any ER Visits. The percentage of participants in each category is reported.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=323 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=322 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants by Resource Utilization Categories
Any Additional Visits (including Urgent Care)
|
1.2 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants by Resource Utilization Categories
Any Additional Procedures
|
1.5 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants by Resource Utilization Categories
Any Additional Tests
|
1.9 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants by Resource Utilization Categories
Any Home Visits or Home Nursing Care
|
1.5 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants by Resource Utilization Categories
Any ER Visits
|
0.3 percentage of participants
|
0.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: EOT (Day 14-15)Population: ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
The SSTI-C Questionnaire is an 11-item self-reported questionnaire that measures subjective experiences of the participant. One of the items assessed was overall satisfaction with treatment. Participants answered the question: "Overall, how satisfied were you with your antibiotic treatment?" using one of the following responses: Extremely satisfied, Moderately satisfied, Not at all satisfied, Slightly satisfied and Very satisfied. The percentage of participants in each category is reported.
Outcome measures
| Measure |
Single-Dose Dalbavancin
n=338 Participants
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=332 Participants
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
Extremely Satisfied
|
53.6 percentage of participants
|
56.9 percentage of participants
|
|
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
Moderately Satisfied
|
9.5 percentage of participants
|
7.2 percentage of participants
|
|
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
Not at all Satisfied
|
0.9 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
Slightly Satisfied
|
0.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
Very Satisfied
|
35.8 percentage of participants
|
33.7 percentage of participants
|
Adverse Events
Single-Dose Dalbavancin
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Two-Dose Dalbavancin
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single-Dose Dalbavancin
n=349 participants at risk
Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.
|
Two-Dose Dalbavancin
n=346 participants at risk
Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
|
|---|---|---|
|
Eye disorders
Vitreous haemorrhage
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.29%
1/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.29%
1/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Skin bacterial infection
|
0.57%
2/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.29%
1/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.29%
1/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.29%
1/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Phlebitis
|
0.29%
1/349 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
0.00%
0/346 • Up to 28 Days
The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees that the first results publication shall be made in conjunction with a joint multi-center publication. If the multi-center publication is not submitted within 18 months after conclusion of the study at all sites, or if the sponsor confirms not to publish the results, the PI may publish the results from the institution subject to terms of the clinical trial agreement. The publication must be sent to Sponsor at least 60 days before the intended submission date for reference and comment.
- Publication restrictions are in place
Restriction type: OTHER