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Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

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ClinicalTrials.gov Identifier: NCT02127970
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 14, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Durata Therapeutics Inc., an affiliate of Allergan plc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Abscess
Wound Infection
Surgical Site Infection
Cellulitis
Interventions Drug: Dalbavancin
Drug: Dalbavancin-matching Placebo
Enrollment 698
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 349 349
Completed 323 322
Not Completed 26 27
Reason Not Completed
Adverse Event             2             1
Death             1             1
Lost to Follow-up             14             14
Reason not Specified             4             7
Pregnancy             0             1
Subject Withdrew Consent             5             3
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 349 349 698
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 349 participants 349 participants 698 participants
48.0  (14.83) 48.3  (14.74) 48.2  (14.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 349 participants 698 participants
Female
145
  41.5%
146
  41.8%
291
  41.7%
Male
204
  58.5%
203
  58.2%
407
  58.3%
1.Primary Outcome
Title Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug
Hide Description 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.
Time Frame Up to 48-72 hours after the initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants regardless of whether or not they received study drug.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 349 349
Measure Type: Number
Unit of Measure: percentage of participants
81.4 84.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-Dose Dalbavancin, Two-Dose Dalbavancin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.
Method of Estimation Estimation Parameter Difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-8.5 to 2.8
Estimation Comments For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.
2.Secondary Outcome
Title Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
Hide Description 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.
Time Frame End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants regardless of whether or not they received study drug.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 349 349
Measure Type: Number
Unit of Measure: percentage of participants
EOT; Clinical Success 84.0 84.8
EOT; Clinical Failure 12.0 10.3
EOT; Indeterminate 4.0 4.9
FV; Clinical Success 84.5 85.1
FV; Clinical Failure 8.0 7.2
FV; Indeterminate 7.4 7.3
3.Other Pre-specified Outcome
Title Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)
Hide Description 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.
Time Frame EOT (Day 14-15)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants regardless of whether or not they received study drug.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 349 349
Measure Type: Number
Unit of Measure: percentage of participants
Clinical Success 84.8 85.4
Clinical Failure 7.7 6.9
Indeterminate 7.4 7.7
4.Other Pre-specified Outcome
Title Percentage of Participants by Investigator Assessment of Clinical Outcome
Hide Description 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.
Time Frame Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 347 344
Measure Type: Number
Unit of Measure: percentage of participants
Successful Outcome (Day 3-4) 93.4 93.0
Unsuccessful Outcome (Day 3-4) 0.3 0.9
Indeterminate (Day 3-4) 6.3 6.1
Successful Outcome (Day 8) 92.2 93.3
Unsuccessful Outcome (Day 8) 0.6 0.3
Indeterminate (Day 8) 7.2 6.4
Successful Outcome (EOT) 92.5 92.7
Unsuccessful Outcome (EOT) 2.9 1.5
Indeterminate (EOT) 4.6 5.8
Successful Outcome (Final Visit) 90.2 91.0
Unsuccessful Outcome (Final Visit) 2.6 1.7
Indeterminate (Final Visit) 7.2 7.3
5.Other Pre-specified Outcome
Title Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
Hide Description 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.
Time Frame Day 3-4 and EOT (Day 14-15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 210 220
Measure Type: Number
Unit of Measure: percentage of participants
Staphylococcus aureus (Day 3-4) Number Analyzed 139 participants 156 participants
88.5 85.3
Streptococcus agalactiae (Day 3-4) Number Analyzed 6 participants 6 participants
100.0 66.7
Streptococcus anginosus group (Day 3-4) Number Analyzed 33 participants 19 participants
93.9 100.0
Streptococcus dysgalactiae (Day 3-4) Number Analyzed 4 participants 3 participants
100.0 100.0
Streptococcus pyogenes (Day 3-4) Number Analyzed 14 participants 22 participants
100.0 81.8
Enterococcus faecalis (Day 3-4) Number Analyzed 4 participants 10 participants
100.0 80.0
Staphylococcus aureus (EOT) Number Analyzed 139 participants 156 participants
87.8 91.7
Streptococcus agalactiae (EOT) Number Analyzed 6 participants 6 participants
83.3 83.3
Streptococcus anginosus group (EOT) Number Analyzed 33 participants 19 participants
81.8 89.5
Streptococcus dysgalactiae (EOT) Number Analyzed 4 participants 3 participants
100.0 100.0
Streptococcus pyogenes (EOT) Number Analyzed 14 participants 22 participants
92.9 81.8
Enterococcus faecalis (EOT) Number Analyzed 4 participants 10 participants
100.0 100.0
6.Other Pre-specified Outcome
Title Percentage of Participants With Complete Resolution of Local Signs of Infection
Hide Description Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration.
Time Frame Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 349 349
Measure Type: Number
Unit of Measure: percentage of participants
Day 3-4 Number Analyzed 321 participants 324 participants
1.9 1.5
Day 8 Number Analyzed 328 participants 329 participants
22.3 21.1
EOT Visit Number Analyzed 334 participants 338 participants
56.3 56.2
Final Visit Number Analyzed 295 participants 295 participants
85.8 89.8
7.Other Pre-specified Outcome
Title Change From Baseline in Participant's Assessment of Pain
Hide Description 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.
Time Frame Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 349 349
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 7.7  (2.09) 7.8  (2.12)
Change from Baseline to Day 3-4 -3.9  (2.46) -3.8  (2.43)
Change from Baseline to Day 8 -5.9  (2.53) -5.8  (2.68)
Change from Baseline to EOT Visit -6.9  (2.37) -6.9  (2.53)
Change from Baseline to Final Visit -7.5  (2.19) -7.4  (2.40)
8.Other Pre-specified Outcome
Title Percentage of Participants by Resource Utilization Categories
Hide Description 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.
Time Frame Final Visit (Day 28 +/- 2 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 323 322
Measure Type: Number
Unit of Measure: percentage of participants
Any Additional Visits (including Urgent Care) 1.2 0.6
Any Additional Procedures 1.5 1.6
Any Additional Tests 1.9 2.8
Any Home Visits or Home Nursing Care 1.5 1.2
Any ER Visits 0.3 0.9
9.Other Pre-specified Outcome
Title Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
Hide Description 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.
Time Frame EOT (Day 14-15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 338 332
Measure Type: Number
Unit of Measure: percentage of participants
Extremely Satisfied 53.6 56.9
Moderately Satisfied 9.5 7.2
Not at all Satisfied 0.9 0.9
Slightly Satisfied 0.3 0.9
Very Satisfied 35.8 33.7
Time Frame Up to 28 Days
Adverse Event Reporting Description 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.
 
Arm/Group Title Single-Dose Dalbavancin Two-Dose Dalbavancin
Hide Arm/Group Description 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 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.
All-Cause Mortality
Single-Dose Dalbavancin Two-Dose Dalbavancin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/349 (0.29%)   1/346 (0.29%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single-Dose Dalbavancin Two-Dose Dalbavancin
Affected / at Risk (%) Affected / at Risk (%)
Total   7/349 (2.01%)   5/346 (1.45%) 
Eye disorders     
Vitreous haemorrhage  1  1/349 (0.29%)  0/346 (0.00%) 
Infections and infestations     
Clostridium difficile colitis  1  0/349 (0.00%)  1/346 (0.29%) 
Necrotising fasciitis  1  0/349 (0.00%)  1/346 (0.29%) 
Pneumonia  1  1/349 (0.29%)  0/346 (0.00%) 
Sepsis  1  1/349 (0.29%)  0/346 (0.00%) 
Skin bacterial infection  1  2/349 (0.57%)  0/346 (0.00%) 
Injury, poisoning and procedural complications     
Toxicity to various agents  1  1/349 (0.29%)  0/346 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/349 (0.29%)  0/346 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  0/349 (0.00%)  1/346 (0.29%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/349 (0.00%)  1/346 (0.29%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  0/349 (0.00%)  1/346 (0.29%) 
Vascular disorders     
Deep vein thrombosis  1  1/349 (0.29%)  0/346 (0.00%) 
Peripheral ischaemia  1  1/349 (0.29%)  0/346 (0.00%) 
Phlebitis  1  1/349 (0.29%)  0/346 (0.00%) 
1
Term from vocabulary, MedDRA, Version 17.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single-Dose Dalbavancin Two-Dose Dalbavancin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/349 (0.00%)   0/346 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI agrees that the first results publication shall be made in conjunction with a joint multi-center publication. If the multi-center publication is not submitted within 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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Durata Therapeutics Inc., an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02127970     History of Changes
Other Study ID Numbers: DUR001-303
First Submitted: April 25, 2014
First Posted: May 1, 2014
Results First Submitted: July 18, 2018
Results First Posted: August 14, 2018
Last Update Posted: September 28, 2018