Abscess, Cellulitis, Surgical Site Infection, Wound Infection
Conditions
Brief summary
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.
Interventions
DRUGDalbavancin
Dalbavancin IV infusion over 30 minutes.
DRUGDalbavancin-matching Placebo
Dalbavancin-matching placebo IV infusion over 30 minutes.
Sponsors
Durata Therapeutics Inc., an affiliate of Allergan plc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants 18 - 85 years of age. * Signed and dated informed consent document. * Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria. * At least two (2) local signs and symptoms of acute bacterial skin and skin structure infection (ABSSSI and at least one systemic sign of infection. * Participant willing and able to comply with study procedures.
Exclusion criteria
* A contra-indication to dalbavancin. * Pregnant or nursing females. * Sustained shock. * Participation in another study of an investigational drug or device within 30 days. * Receipt of a systemically or topically administered antibiotic with a Gram-positive spectrum that achieves therapeutic concentrations in the serum or at the site of the ABSSSI within 14 days prior to randomization. An exception is allowed for participants receiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug prior to randomization; up to 25% of participants may have received such therapy. * Infection due to an organism known prior to study entry to be resistant to dalbavancin or vancomycin (vancomycin MIC (minimum inhibitory concentration) \>8 μg/mL). * Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis; endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis. * Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen. * Venous catheter entry site infection. * Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer. * Participant with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis catheter, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter. * Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the participant should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia. Such participants must have an end of treatment (EOT) visit performed within 3 calendar days after discontinuing study medication but are required to have AEs (adverse events) reported through the Final Visit. * Participants whose ABSSSI is the result of having sustained full or partial thickness burns. * Participants with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of \<45 mm Hg, ankle brachial index \<0.5, and/ or critical ischemia as assessed by a vascular surgeon. * Participants with ABSSSI such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. * Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study. * Anticipated need of antibiotic therapy for longer than 14 days. * Participants who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI. * More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the ABSSSI, or participants who are expected to require more than 2 such interventions. * Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity). * Absolute neutrophil count \<500 cells/mm\^3. * Known or suspected human immunodeficiency virus (HIV) infected participants with a CD4 (cluster of differentiation 4) cell count \<200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count. * Participants with a recent bone marrow transplant (in post-transplant hospital stay). * Participants receiving oral steroids \>20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation. * Participants with a rapidly fatal illness, who are not expected to survive for 3 months. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participants inappropriate for entry into this study. * Prior participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug | Up to 48-72 hours after the initiation of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Day 3-4 and EOT (Day 14-15) | 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. |
| Percentage of Participants With Complete Resolution of Local Signs of Infection | Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days) | Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration. |
| Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT) | EOT (Day 14-15) | 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. |
| Percentage of Participants by Resource Utilization Categories | Final Visit (Day 28 +/- 2 days) | 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. |
| Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | EOT (Day 14-15) | 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. |
| Change From Baseline in Participant's Assessment of Pain | Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days) | 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. |
| Percentage of Participants by Investigator Assessment of Clinical Outcome | Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days) | 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. |
Countries
Bulgaria, Croatia, Estonia, Georgia, Hungary, Latvia, Romania, Russia, Serbia, South Africa, Ukraine, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 349 |
| 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. | 349 |
| Total | 698 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 14 | 14 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Reason not Specified | 4 | 7 |
| Overall Study | Subject Withdrew Consent | 5 | 3 |
Baseline characteristics
| Characteristic | Single-Dose Dalbavancin | Two-Dose Dalbavancin | Total |
|---|---|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 14.83 | 48.3 years STANDARD_DEVIATION 14.74 | 48.2 years STANDARD_DEVIATION 14.78 |
| Sex: Female, Male Female | 145 Participants | 146 Participants | 291 Participants |
| Sex: Female, Male Male | 204 Participants | 203 Participants | 407 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 349 | 1 / 346 |
| other Total, other adverse events | 0 / 349 | 0 / 346 |
| serious Total, serious adverse events | 7 / 349 | 5 / 346 |
Outcome results
Primary
Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of 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.
Time frame: Up to 48-72 hours after the initiation of study drug
Population: ITT Population included all randomized participants regardless of whether or not they received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Dose Dalbavancin | Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug | 81.4 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug | 84.2 percentage of participants |
95% CI: [-8.5, 2.8]
Secondary
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
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)
Population: ITT Population included all randomized participants regardless of whether or not they received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | EOT; Clinical Success | 84.0 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | EOT; Clinical Failure | 12.0 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | EOT; Indeterminate | 4.0 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | FV; Clinical Success | 84.5 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | FV; Clinical Failure | 8.0 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | FV; Indeterminate | 7.4 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | FV; Clinical Failure | 7.2 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | EOT; Clinical Success | 84.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | FV; Clinical Success | 85.1 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | EOT; Clinical Failure | 10.3 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | FV; Indeterminate | 7.3 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV) | EOT; Indeterminate | 4.9 percentage of participants |
Other Pre-specified
Change From Baseline in Participant's Assessment of Pain
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-Dose Dalbavancin | Change From Baseline in Participant's Assessment of Pain | Baseline | 7.7 Scores on a scale | Standard Deviation 2.09 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Two-Dose Dalbavancin | Change From Baseline in Participant's Assessment of Pain | Change from Baseline to Day 8 | -5.8 Scores on a scale | Standard Deviation 2.68 |
| Two-Dose Dalbavancin | Change From Baseline in Participant's Assessment of Pain | Baseline | 7.8 Scores on a scale | Standard Deviation 2.12 |
| Two-Dose Dalbavancin | Change From Baseline in Participant's Assessment of Pain | Change from Baseline to Final Visit | -7.4 Scores on a scale | Standard Deviation 2.4 |
| Two-Dose Dalbavancin | Change From Baseline in Participant's Assessment of Pain | Change from Baseline to Day 3-4 | -3.8 Scores on a scale | Standard Deviation 2.43 |
| Two-Dose Dalbavancin | Change From Baseline in Participant's Assessment of Pain | Change from Baseline to EOT Visit | -6.9 Scores on a scale | Standard Deviation 2.53 |
Other Pre-specified
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Staphylococcus aureus (EOT) | 87.8 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus agalactiae (EOT) | 83.3 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus anginosus group (EOT) | 81.8 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus dysgalactiae (EOT) | 100.0 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus pyogenes (EOT) | 92.9 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Enterococcus faecalis (EOT) | 100.0 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus pyogenes (EOT) | 81.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Staphylococcus aureus (Day 3-4) | 85.3 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Staphylococcus aureus (EOT) | 91.7 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus agalactiae (Day 3-4) | 66.7 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus dysgalactiae (EOT) | 100.0 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus anginosus group (Day 3-4) | 100.0 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus agalactiae (EOT) | 83.3 percentage of participants |
| Two-Dose Dalbavancin | 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 |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Enterococcus faecalis (EOT) | 100.0 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus pyogenes (Day 3-4) | 81.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Streptococcus anginosus group (EOT) | 89.5 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline | Enterococcus faecalis (Day 3-4) | 80.0 percentage of participants |
Other Pre-specified
Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)
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)
Population: ITT Population included all randomized participants regardless of whether or not they received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT) | Indeterminate | 7.4 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT) | Clinical Success | 85.4 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT) | Clinical Failure | 6.9 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT) | Indeterminate | 7.7 percentage of participants |
Other Pre-specified
Percentage of Participants by Investigator Assessment of Clinical Outcome
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (Day 3-4) | 93.4 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (Day 3-4) | 0.3 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (Day 3-4) | 6.3 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (Day 8) | 92.2 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (Day 8) | 0.6 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (Day 8) | 7.2 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (EOT) | 92.5 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (EOT) | 2.9 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (EOT) | 4.6 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (Final Visit) | 90.2 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (Final Visit) | 2.6 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (Final Visit) | 7.2 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (Final Visit) | 1.7 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (Day 3-4) | 93.0 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (EOT) | 92.7 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (Day 3-4) | 0.9 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (Final Visit) | 91.0 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (Day 3-4) | 6.1 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (EOT) | 1.5 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Successful Outcome (Day 8) | 93.3 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (Final Visit) | 7.3 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Unsuccessful Outcome (Day 8) | 0.3 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (EOT) | 5.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Investigator Assessment of Clinical Outcome | Indeterminate (Day 8) | 6.4 percentage of participants |
Other Pre-specified
Percentage of Participants by Resource Utilization Categories
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Additional Procedures | 1.5 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Home Visits or Home Nursing Care | 1.5 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Additional Tests | 1.9 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any ER Visits | 0.3 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Additional Visits (including Urgent Care) | 1.2 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any ER Visits | 0.9 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Additional Visits (including Urgent Care) | 0.6 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Additional Procedures | 1.6 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Additional Tests | 2.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Resource Utilization Categories | Any Home Visits or Home Nursing Care | 1.2 percentage of participants |
Other Pre-specified
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Moderately Satisfied | 9.5 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Slightly Satisfied | 0.3 percentage of participants |
| Single-Dose Dalbavancin | 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 |
| Single-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Very Satisfied | 35.8 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Extremely Satisfied | 53.6 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Very Satisfied | 33.7 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Extremely Satisfied | 56.9 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Moderately Satisfied | 7.2 percentage of participants |
| Two-Dose Dalbavancin | 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 |
| Two-Dose Dalbavancin | Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response | Slightly Satisfied | 0.9 percentage of participants |
Other Pre-specified
Percentage of Participants With Complete Resolution of Local Signs of Infection
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | Day 3-4 | 1.9 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | Day 8 | 22.3 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | EOT Visit | 56.3 percentage of participants |
| Single-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | Final Visit | 85.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | Final Visit | 89.8 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | Day 3-4 | 1.5 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | EOT Visit | 56.2 percentage of participants |
| Two-Dose Dalbavancin | Percentage of Participants With Complete Resolution of Local Signs of Infection | Day 8 | 21.1 percentage of participants |