Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
Conditions
Keywords
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Brief summary
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Interventions
DRUGDalbavancin
Dalbavancin was administered intravenously over 30 (± 5) minutes.
DRUGVancomycin
Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
DRUGOxacillin
Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
DRUGFlucloxacillin
Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
DRUGCefadroxil
Cefadroxil was administered orally every 12 hours.
DRUGClindamycin
Clindamycin was administered orally every 8 hours.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients birth to 17 years (inclusive) * A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA). * In addition to local signs of ABSSSI, the patient has at least one of the following: * Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR * Leukocytosis (WBC \> 10,000 mm3) or leukopenia (WBC \< 2,000 mm3) or left shift of \>10% band neutrophils * Infection either involving deeper soft tissue or requiring significant surgical intervention * Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration * In patients age birth to \< 3 months, each patient must meet the following inclusion criteria to be enrolled in this study. 1. Male or female patients from birth to \< 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks) 2. A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA. OR Suspected or confirmed sepsis including any of the following clinical criteria: 1. Hypothermia (\<36°C) OR fever (\>38.5°C) 2. Bradycardia OR tachycardia OR rhythm instability 3. Hypotension OR mottled skin OR impaired peripheral perfusion 4. Petechial rash 5. New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support 6. Feeding intolerance OR poor sucking OR abdominal distension 7. Irritability 8. Lethargy 9. Hypotonia 3. In addition, patients must meet at least one of the following laboratory criteria: a. White blood cell count ≤4.0 × 10\^9/L OR ≥20.0 × 10\^9/L b, Immature to total neutrophil ratio \>0.2 c. Platelet count ≤100 × 10\^9/L d. C-reactive protein (CRP) \>15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis 4. Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include: 1. Cutaneous or subcutaneous abscess 2. Surgical site or traumatic wound infection 3. Cellulitis, Erysipelas 4. Omphalitis 5. Impetigo and bullous impetigo 6. Pustular folliculitis 7. Scarlet fever 8. Staphylococcal scalded skin syndrome 9. Streptococcal toxic shock syndrome 10. Erythematous based-erosion 11. Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2. 5. Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.
Exclusion criteria
1. Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz bedside formula). Patients birth to \< 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output \< 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis. 2. Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age. 3. Treatment with an investigational drug within 30 days preceding the first dose of study medication. 4. Patients with sustained shock defined as systolic blood pressure \< 90 mm Hg in children ≥ 10 years old, \< 70 mm Hg + \[2 x age in years\] in children 1 to \<10 years, or \< 70 mmHg in infants 3 to \<12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure. 5. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms. 6. Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL). 7. Patients with necrotizing fasciitis, or deep-seated infections that would require \> 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis). 8. 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. 9. Venous catheter entry site infection. 10. Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer. 11. Patient 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, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter. 12. 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 patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia. 13. Patients whose skin infection is the result of having sustained full or partial thickness burns. 14. Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to \< 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy. 15. Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study. 16. Sickle cell anemia 17. Cystic fibrosis 18. Anticipated need of antibiotic therapy for longer than 14 days. 19. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI. 20. More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions. 21. 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). 22. Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count \< 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for \> 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count\< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count. 23. Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins. 24. Patients with a rapidly fatal illness, who are not expected to survive for 3 months. 25. Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing). 26. Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline, Day 28 (± 2 days) | Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment. |
| Shift From Baseline in Auditory Brainstem Response Test at TOC Visit | Baseline, Day 28 (± 2 days) | Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment. |
| Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | Baseline, Day 28 (± 2 days) | Bowel flora was evaluated in participants from birth to \< 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit. |
| Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline, Day 28 (± 2 days) | Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment. |
| Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline, Day 28 (± 2 days) | Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Baseline, Day 54 (± 7 days) | Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population |
| Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Baseline, Day 54 (± 7 days) | Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism. |
| Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | Baseline, 48-72 hours | Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Baseline, Day 14 (± 2 Days) | Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx. Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Baseline, Day 14 (± 2 Days) | Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Baseline, Day 28 (± 2 Days) | Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Baseline, Day 28 (± 2 Days) | Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | Baseline, Day 54 (± 7 days) | Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | Baseline, Day 54 (± 7 days) | Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response at 48-72 Hours | Baseline, 48-72 hours | Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism. |
| Microbiological Response at the End of Treatment (EOT) Visit | Baseline, Day 14 (± 2 Days) | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Microbiological Response at the Test of Cure (TOC) Visit | Baseline, Day 28 (± 2 Days) | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Microbiological Response at the Follow-Up Visit | Baseline, Day 54 (± 7 days) | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | Baseline, 48-72 hours | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing., Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | Baseline, Day 14 (± 2 Days) | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | Baseline, Day 28 (± 2 Days) | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | Baseline, Day 54 (± 7 days) | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants | Day 28 (± 2 Days) | All-cause mortality was determined for the participants in Cohort 5 (birth to \< 3 months) at the Test of Cure visit. |
| Concentration of Dalbavancin in Plasma | 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV | The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration. |
| Microbiological Response at 48-72 Hours | Baseline, 48-72 hours | Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline. |
| Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Baseline, Day 14 (± 2 Days) | Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the modified intent-to-treat (mITT) population. |
| Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Baseline, Day 14 (± 2 Days) | Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism. |
| Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Baseline, Day 28 (± 2 Days) | Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population. |
| Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Baseline, Day 28 (± 2 Days) | Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism. |
Countries
Argentina, Belarus, Brazil, Bulgaria, Chile, Colombia, Georgia, Greece, Guatemala, Latvia, Lithuania, Mexico, Panama, Poland, Romania, Russia, South Africa, Spain, Ukraine, United States
Participant flow
Pre-assignment details
Intent-to-Treat (ITT) population: all randomized participants
Participants by arm
| Arm | Count |
|---|---|
| Dalbavancin Single-dose Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose. | 91 |
| Dalbavancin Two-dose Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8. | 78 |
| Comparator Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs. | 30 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Other, not specified | 0 | 1 | 0 |
| Overall Study | Withdrawal of consent | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Dalbavancin Single-dose | Dalbavancin Two-dose | Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 7.591 years STANDARD_DEVIATION 5.4767 | 8.898 years STANDARD_DEVIATION 4.9271 | 6.775 years STANDARD_DEVIATION 4.2048 | 7.980 years STANDARD_DEVIATION 5.127 |
| Age, Customized 12 years to 17 years old (Cohort 1) | 29 Participants | 29 Participants | 6 Participants | 64 Participants |
| Age, Customized 2 years to < 6 years old (Cohort 3) | 18 Participants | 17 Participants | 10 Participants | 45 Participants |
| Age, Customized 3 months to < 2 years old (Cohort 4) | 9 Participants | 8 Participants | 3 Participants | 20 Participants |
| Age, Customized 6 years to < 12 years old (Cohort 2) | 25 Participants | 24 Participants | 11 Participants | 60 Participants |
| Age, Customized Birth to < 3 months (Cohort 5) | 10 Participants | 0 Participants | 0 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 1 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 71 Participants | 29 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 78 Participants | 69 Participants | 29 Participants | 176 Participants |
| Sex: Female, Male Female | 38 Participants | 25 Participants | 12 Participants | 75 Participants |
| Sex: Female, Male Male | 53 Participants | 53 Participants | 18 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 78 | 0 / 30 |
| other Total, other adverse events | 1 / 91 | 5 / 78 | 1 / 30 |
| serious Total, serious adverse events | 3 / 91 | 0 / 78 | 0 / 30 |
Outcome results
Primary
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalbavancin Single-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline & TOC normal | 8 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline & TOC normal | 4 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Comparator | Shift From Baseline in Acoustic Immittance Test at TOC Visit | Baseline & TOC normal | 3 Participants |
Primary
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalbavancin Single-dose | Shift From Baseline in Auditory Brainstem Response Test at TOC Visit | Baseline & TOC normal | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Auditory Brainstem Response Test at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Auditory Brainstem Response Test at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Auditory Brainstem Response Test at TOC Visit | Baseline & TOC abnormal | 0 Participants |
Primary
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalbavancin Single-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline & TOC normal | 8 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline & TOC normal | 5 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Comparator | Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit | Baseline & TOC normal | 4 Participants |
Primary
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
Bowel flora was evaluated in participants from birth to \< 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
Time frame: Baseline, Day 28 (± 2 days)
Population: Participants aged birth to \< 2 years who received at least 1 dose of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC negative | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline positive & TOC missing | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC missing | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline positive & TOC negative | 3 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline positive & TOC negative | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC positive | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC missing | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline & TOC positive | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC negative | 2 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC positive | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC missing | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline positive & TOC missing | 2 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline & TOC positive | 1 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC negative | 15 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC positive | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC missing | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC positive | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC negative | 10 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline positive & TOC missing | 1 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC missing | 2 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC positive | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline & TOC positive | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline positive & TOC negative | 1 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline & TOC positive | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC positive | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC negative | 4 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC missing | 1 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC positive | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC negative | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC missing | 1 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline positive & TOC negative | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline positive & TOC missing | 1 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC positive | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC negative | 5 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC negative | 0 Participants |
| Dalbavancin Two-dose | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC missing | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC negative | 1 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC missing | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline positive & TOC missing | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC positive | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC negative | 1 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC positive | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline positive & TOC missing | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline & TOC positive | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC negative | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline negative & TOC missing | 2 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline positive & TOC negative | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC negative | 1 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline missing & TOC positive | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC missing | 1 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline missing & TOC positive | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline negative & TOC missing | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | C diff Baseline & TOC positive | 0 Participants |
| Comparator | Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit | VRE Baseline positive & TOC negative | 0 Participants |
Primary
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Time frame: Baseline, Day 28 (± 2 days)
Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalbavancin Single-dose | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline & TOC normal | 2 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Dalbavancin Single-dose | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline & TOC abnormal | 0 Participants |
| Comparator | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline & TOC normal | 1 Participants |
| Comparator | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline abnormal & TOC normal | 0 Participants |
| Comparator | Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit | Baseline normal & TOC abnormal | 0 Participants |
Secondary
All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants
All-cause mortality was determined for the participants in Cohort 5 (birth to \< 3 months) at the Test of Cure visit.
Time frame: Day 28 (± 2 Days)
Population: All participants in the ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dalbavancin Single-dose | All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants | 0 Participants |
Secondary
Clinical Response at 48-72 Hours
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, 48-72 hours
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at 48-72 Hours | Clinical Responder | 96.5 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at 48-72 Hours | Clinical Non-Responder | 3.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at 48-72 Hours | Clinical Responder | 98.6 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at 48-72 Hours | Clinical Non-Responder | 1.4 percentage of participants |
| Comparator | Clinical Response at 48-72 Hours | Clinical Responder | 89.7 percentage of participants |
| Comparator | Clinical Response at 48-72 Hours | Clinical Non-Responder | 10.3 percentage of participants |
Secondary
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, Day 14 (± 2 Days)
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Cure | 90.5 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Improvement | 7.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Failure | 2.4 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Cure | 91.9 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Failure | 2.7 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Improvement | 5.4 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Improvement | 0 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Failure | 0 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | Cure | 100 percentage of participants |
Secondary
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the modified intent-to-treat (mITT) population.
Time frame: Baseline, Day 14 (± 2 Days)
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 92.9 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Improvement | 6.0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 1.2 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 93.2 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 1.4 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Improvement | 5.5 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Improvement | 0 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 100 percentage of participants |
Secondary
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, Day 54 (± 7 days)
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Unknown | 1.2 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Failure | 2.4 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Cure | 96.4 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Cure | 97.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Failure | 2.7 percentage of participants |
| Comparator | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Failure | 0 percentage of participants |
| Comparator | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Cure | 100 percentage of participants |
| Comparator | Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
Secondary
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population
Time frame: Baseline, Day 54 (± 7 days)
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 1.2 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 97.6 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Unknown | 1.2 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 1.4 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 97.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Unknown | 1.4 percentage of participants |
| Comparator | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 0 percentage of participants |
Secondary
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Time frame: Baseline, Day 28 (± 2 Days)
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Unknown | 2.4 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Failure | 2.4 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Cure | 95.2 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Failure | 2.7 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Cure | 97.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Cure | 100 percentage of participants |
| Comparator | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | Failure | 0 percentage of participants |
Secondary
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population.
Time frame: Baseline, Day 28 (± 2 Days)
Population: Participants in the mITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 1.2 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 98.8 percentage of participants |
| Dalbavancin Single-dose | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 1.4 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 98.6 percentage of participants |
| Dalbavancin Two-dose | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Unknown | 0 percentage of participants |
| Comparator | Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | Clinical Failure | 0 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, 48-72 hours
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Clinical Responder | 97.9 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MRSA),Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. anginosus, Clinical Responder | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. anginosus, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | E. faecalis, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Clinical Non-Responder | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | E. faecalis, Clinical Responder | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Clinical Responder | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MRSA),Clinical Responder | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Clinical Non-Responder | 20 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | E. faecalis, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MRSA),Clinical Responder | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MRSA),Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Clinical Responder | 95.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 2.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. agalactiae, Clinical Responder | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. agalactiae, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. constellatus, Clinical Responder | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. constellatus, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. intermedius, Clinical Responder | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. intermedius, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Clinical Responder | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Clinical Non-Responder | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | E. faecalis, Clinical Responder | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Clinical Non-Responder | 2.3 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Clinical Responder | 85.7 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Clinical Responder | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Clinical Non-Responder | 7.1 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. pyogenes, Clinical Non-Responder | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 7.1 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. anginosus, Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. anginosus, Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. anginosus, Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. anginosus, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 91.5 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 20 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Improvement | 4.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 50 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Improvement | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Failure | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 86.4 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Improvement | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. agalactiae, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. agalactiae, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. agalactiae, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. agalactiae, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. constellatus, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. constellatus, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. constellatus, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. constellatus, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. intermedius, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. intermedius, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. intermedius, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. intermedius, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | E. faecalis, Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Improvement | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Improvement | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 100 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx. Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 91.5 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Improvement | 4.3 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 20 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Improvement | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Improvement | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 86.4 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Improvement | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 2.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 6.8 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 50 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Improvement | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Improvement | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Improvement | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 0 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. anginosus, Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. anginosus, Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. anginosus, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Missing | 50 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | E. faecalis, Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | E. faecalis, Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Cure | 50 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 20 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 93.6 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. intermedius, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Cure | 50 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Failure | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 88.6 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 6.8 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. agalactiae, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. agalactiae, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. agalactiae, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. constellatus, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. constellatus, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. constellatus, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. intermedius, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. intermedius, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | E. faecalis, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | E. faecalis, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | E. faecalis, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 0 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Unknown | 50 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Cure | 50 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 20 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 95.7 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Cure | 50 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Unknown | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 88.6 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 2.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 9.1 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 0 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. anginosus, Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. anginosus, Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. anginosus, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | E. faecalis, Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 4.3 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 91.5 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | E. faecalis, Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 20 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. constellatus, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Failure | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 90.9 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 4.5 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. agalactiae, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. agalactiae, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. agalactiae, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. constellatus, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. constellatus, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. intermedius, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. intermedius, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. intermedius, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | E. faecalis, Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | E. faecalis, Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | E. faecalis, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. pyogenes, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor) | S. aureus (MSSA),Missing | 0 percentage of participants |
Secondary
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 2.1 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 80 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 20 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. anginosus, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 2.2 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Failure | 0 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Cure | 100 percentage of participants |
| Dalbavancin Single-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 95.7 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 90.9 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 2.3 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 6.8 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. agalactiae, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. constellatus, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. intermedius, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Cure | 100 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | E. faecalis, Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Cure | 75 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Clinical Failure | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Unknown | 0 percentage of participants |
| Dalbavancin Two-dose | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MRSA),Missing | 25 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Cure | 100 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Missing | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Unknown | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. pyogenes, Clinical Failure | 0 percentage of participants |
| Comparator | Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome) | S. aureus (MSSA),Unknown | 0 percentage of participants |
Secondary
Concentration of Dalbavancin in Plasma
The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration.
Time frame: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV
Population: All participants in the ITT population who received at least 1 dose of study drug with available data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dalbavancin Single-dose | Concentration of Dalbavancin in Plasma | 168 hrs after start of IV | 16.89 µg/mL | Geometric Coefficient of Variation 35.12 |
| Dalbavancin Single-dose | Concentration of Dalbavancin in Plasma | 30 min (end of infusion) | 212.43 µg/mL | Geometric Coefficient of Variation 23.32 |
| Dalbavancin Single-dose | Concentration of Dalbavancin in Plasma | 312 hrs after start of IV | 4.94 µg/mL | Geometric Coefficient of Variation 47.91 |
| Dalbavancin Single-dose | Concentration of Dalbavancin in Plasma | 2 hrs after start of IV | 133.83 µg/mL | Geometric Coefficient of Variation 24.66 |
| Dalbavancin Single-dose | Concentration of Dalbavancin in Plasma | 48-72 hrs after start of IV | 53.53 µg/mL | Geometric Coefficient of Variation 24.48 |
| Dalbavancin Two-dose | Concentration of Dalbavancin in Plasma | 168 hrs after start of IV | 28.80 µg/mL | Geometric Coefficient of Variation 119.04 |
| Dalbavancin Two-dose | Concentration of Dalbavancin in Plasma | 48-72 hrs after start of IV | 61.32 µg/mL | Geometric Coefficient of Variation 40.08 |
| Dalbavancin Two-dose | Concentration of Dalbavancin in Plasma | 2 hrs after start of IV | 196.51 µg/mL | Geometric Coefficient of Variation 53.44 |
| Dalbavancin Two-dose | Concentration of Dalbavancin in Plasma | 312 hrs after start of IV | 15.24 µg/mL | Geometric Coefficient of Variation 47.97 |
| Dalbavancin Two-dose | Concentration of Dalbavancin in Plasma | 30 min (end of infusion) | 268.02 µg/mL | Geometric Coefficient of Variation 44.9 |
| Comparator | Concentration of Dalbavancin in Plasma | 48-72 hrs after start of IV | 56.68 µg/mL | Geometric Coefficient of Variation 46.25 |
| Comparator | Concentration of Dalbavancin in Plasma | 30 min (end of infusion) | 219.45 µg/mL | Geometric Coefficient of Variation 66.72 |
| Comparator | Concentration of Dalbavancin in Plasma | 2 hrs after start of IV | 149.28 µg/mL | Geometric Coefficient of Variation 43.4 |
| Comparator | Concentration of Dalbavancin in Plasma | 168 hrs after start of IV | 24.10 µg/mL | Geometric Coefficient of Variation 80.9 |
| Comparator | Concentration of Dalbavancin in Plasma | 312 hrs after start of IV | 12.74 µg/mL | Geometric Coefficient of Variation 45.62 |
| Participants Aged 6 Years to < 12 Years Old | Concentration of Dalbavancin in Plasma | 312 hrs after start of IV | 15.35 µg/mL | Geometric Coefficient of Variation 39.4 |
| Participants Aged 6 Years to < 12 Years Old | Concentration of Dalbavancin in Plasma | 30 min (end of infusion) | 211.30 µg/mL | Geometric Coefficient of Variation 34.26 |
| Participants Aged 6 Years to < 12 Years Old | Concentration of Dalbavancin in Plasma | 168 hrs after start of IV | 26.25 µg/mL | Geometric Coefficient of Variation 51.38 |
| Participants Aged 6 Years to < 12 Years Old | Concentration of Dalbavancin in Plasma | 48-72 hrs after start of IV | 56.93 µg/mL | Geometric Coefficient of Variation 39.79 |
| Participants Aged 6 Years to < 12 Years Old | Concentration of Dalbavancin in Plasma | 2 hrs after start of IV | 165.75 µg/mL | Geometric Coefficient of Variation 37.46 |
| 12 Years to 17 Years Old (Cohort 1) | Concentration of Dalbavancin in Plasma | 48-72 hrs after start of IV | 60.92 µg/mL | Geometric Coefficient of Variation 28.68 |
| 12 Years to 17 Years Old (Cohort 1) | Concentration of Dalbavancin in Plasma | 168 hrs after start of IV | 31.41 µg/mL | Geometric Coefficient of Variation 31.24 |
| 12 Years to 17 Years Old (Cohort 1) | Concentration of Dalbavancin in Plasma | 30 min (end of infusion) | 233.58 µg/mL | Geometric Coefficient of Variation 46.44 |
| 12 Years to 17 Years Old (Cohort 1) | Concentration of Dalbavancin in Plasma | 312 hrs after start of IV | 20.75 µg/mL | Geometric Coefficient of Variation 37.71 |
| 12 Years to 17 Years Old (Cohort 1) | Concentration of Dalbavancin in Plasma | 2 hrs after start of IV | 162.54 µg/mL | Geometric Coefficient of Variation 36.85 |
Secondary
Microbiological Response at 48-72 Hours
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, 48-72 hours
Population: Participants in the microITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours | Presumed persistence | 1.9 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours | Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours | Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours | Presumed eradication | 98.1 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours | Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours | Persistence | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours | Eradication | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours | Presumed eradication | 94.4 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours | Presumed persistence | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours | Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours | Indeterminate | 5.6 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours | Presumed persistence | 5.6 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours | Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours | Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours | Presumed eradication | 88.9 percentage of participants |
Secondary
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing., Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, 48-72 hours
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 97.9 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 2.1 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. anginosus, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. anginosus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. anginosus, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. anginosus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. anginosus, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 80 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 20 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. hirae, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. hirae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. hirae, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. hirae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. hirae, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | G. morbillorum, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | G. morbillorum, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | G. morbillorum, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | G. morbillorum, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | G. morbillorum, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | L. lactis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | L. lactis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | L. lactis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | L. lactis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | L. lactis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. intermedius, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. agalactiae, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. agalactiae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. agalactiae, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. agalactiae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. agalactiae, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. constellatus, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. constellatus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. constellatus, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. constellatus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. constellatus, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. intermedius, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. intermedius, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. intermedius, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. intermedius, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 90.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 75 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 2.3 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 7.1 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 85.7 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 7.1 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
Secondary
Microbiological Response at the End of Treatment (EOT) Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Population: Participants in the microITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit | Presumed persistence | 1.9 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit | Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit | Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit | Presumed eradication | 96.2 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit | Indeterminate | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit | Persistence | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit | Eradication | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit | Presumed eradication | 92.6 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit | Presumed persistence | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit | Indeterminate | 1.9 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit | Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit | Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit | Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit | Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit | Presumed eradication | 100 percentage of participants |
Secondary
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 14 (± 2 Days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. anginosus, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. anginosus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. anginosus, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | L. lactis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | L. lactis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 95.7 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | L. lactis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | L. lactis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. hirae, Indeterminate | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. hirae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 2.1 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. hirae, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. hirae, Presumed eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 20 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 2.1 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. hirae, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 80 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | L. lactis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. anginosus, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. anginosus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 75 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 88.6 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. intermedius, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. constellatus, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. constellatus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. constellatus, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. constellatus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. constellatus, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. intermedius, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. intermedius, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. intermedius, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. intermedius, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 75 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
Secondary
Microbiological Response at the Follow-Up Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Population: Participants in the microITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit | Presumed persistence | 1.9 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit | Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit | Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit | Presumed eradication | 94.2 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit | Indeterminate | 3.8 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit | Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit | Eradication | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit | Presumed eradication | 88.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit | Presumed persistence | 3.7 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit | Indeterminate | 5.6 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit | Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit | Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit | Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit | Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit | Presumed eradication | 100 percentage of participants |
Secondary
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 54 (± 7 days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 4.3 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 93.6 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 20 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 80 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. anginosus, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. anginosus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. anginosus, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. anginosus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. anginosus, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 2.1 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 50 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. hirae, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. hirae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. hirae, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. hirae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. hirae, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | G. morbillorum, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | G. morbillorum, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | G. morbillorum, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | G. morbillorum, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | G. morbillorum, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | L. lactis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | L. lactis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | L. lactis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | L. lactis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | L. lactis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 50 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 50 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 4.5 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. agalactiae, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. constellatus, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. intermedius, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 86.4 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 4.5 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. agalactiae, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. agalactiae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. agalactiae, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. agalactiae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. constellatus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. constellatus, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. constellatus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. constellatus, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. intermedius, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. intermedius, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. intermedius, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. intermedius, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 75 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Comparator | Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
Secondary
Microbiological Response at the Test of Cure (TOC) Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Population: Participants in the microITT population with non-missing analysis values at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit | Presumed persistence | 1.9 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit | Indeterminate | 5.8 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit | Presumed eradication | 92.3 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit | Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit | Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit | Presumed eradication | 92.6 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit | Presumed persistence | 3.7 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit | Eradication | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit | Indeterminate | 1.9 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit | Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit | Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit | Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit | Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit | Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit | Presumed persistence | 0 percentage of participants |
Secondary
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Time frame: Baseline, Day 28 (± 2 Days)
Population: Participants in the microITT population with specified baseline pathogen
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 2.1 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 6.4 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. anginosus, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 80 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 20 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. hirae, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. hirae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. hirae, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. hirae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. hirae, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. anginosus, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. anginosus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. anginosus, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. anginosus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | G. morbillorum, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | L. lactis, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | L. lactis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | L. lactis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | L. lactis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 91.5 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Dalbavancin Single-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | L. lactis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. intermedius, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 75 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed eradication | 75 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Presumed persistence | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MRSA), Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 88.6 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 4.5 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. agalactiae, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. constellatus, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. constellatus, Presumed eradication | 100 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. constellatus, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. constellatus, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. constellatus, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. intermedius, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. intermedius, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. intermedius, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. intermedius, Indeterminate | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 2.3 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 25 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Eradication | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed persistence | 0 percentage of participants |
| Dalbavancin Two-dose | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | E. faecalis, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Missing | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Missing | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. aureus (MSSA), Presumed eradication | 100 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Indeterminate | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Presumed persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. mitis/oralis, Persistence | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Eradication | 0 percentage of participants |
| Comparator | Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen | S. pyogenes, Persistence | 0 percentage of participants |