Dalbavancin for the Treatment of Acute Bacterial Skin and... | NCT02814916

ID	Type	Description	Link
2014-005281-30	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dalbavancin single-dose	Experimental	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.	Drug: Dalbavancin
Dalbavancin two-dose	Experimental	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.	Drug: Dalbavancin
Comparator	Active 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.

Name	Type	Description	Arm Group Labels	Other Names
Dalbavancin	Drug	Dalbavancin was administered intravenously over 30 (± 5) minutes.	Dalbavancin single-dose Dalbavancin two-dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, Day 28 (± 2 days)
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.	Baseline, Day 28 (± 2 days)
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.

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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:

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.
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.
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
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.
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.
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).
Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
Venous catheter entry site infection.
Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
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.
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.
Patients whose skin infection is the result of having sustained full or partial thickness burns.
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.
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.
Sickle cell anemia
Cystic fibrosis
Anticipated need of antibiotic therapy for longer than 14 days.
Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions.
Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
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.
Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins.
Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing).
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).

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama /ID# 237446		Mobile	Alabama	36604-3302	United States
Valleywise Health Medical Center /ID# 234343

Label	URL
Related info	View source

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 18, 2022	Aug 15, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Participants who received at least 1 dose of study drug and had baseline and postbaseline values

Posted

Count of Participants

Participants

Baseline, Day 28 (± 2 days)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG0002 OG0010 OG0021

Title

Denominators

Categories

Baseline & TOC normal

Title	Measurements
	OG0002 OG0021

Baseline normal & TOC abnormal

Title	Measurements
	OG000

Primary

Shift From Baseline in Auditory Brainstem Response Test at TOC Visit

Participants who received at least 1 dose of study drug and had baseline and postbaseline values

Posted

Count of Participants

Participants

Baseline, Day 28 (± 2 days)

ID	Title	Description
OG000	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.
OG001	Dalbavancin Two-dose

Primary

Shift From Baseline in Acoustic Immittance Test at TOC Visit

Participants who received at least 1 dose of study drug and had baseline and postbaseline values

Posted

Count of Participants

Participants

Baseline, Day 28 (± 2 days)

ID	Title	Description
OG000	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.
OG001	Dalbavancin Two-dose

Primary

Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit

Participants who received at least 1 dose of study drug and had baseline and postbaseline values

Posted

Count of Participants

Participants

Baseline, Day 28 (± 2 days)

ID	Title	Description
OG000	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.
OG001	Dalbavancin Two-dose

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.

Participants aged birth to < 2 years who received at least 1 dose of study drug

Posted

Count of Participants

Participants

Baseline, Day 28 (± 2 days)

ID	Title	Description
OG000	Dalbavancin Single-dose	Participants received dalbavancin administered intravenously as follows: birth to < 3 months of age 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.
OG001	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.
OG002	Comparator

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.

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, 48-72 hours

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 14 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	Dalbavancin Two-dose

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.

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 14 (± 2 Days)

ID	Title	Description
OG000	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.

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.

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 28 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 28 (± 2 Days)

ID	Title	Description
OG000	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.

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

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 54 (± 7 days)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)

Participants in the mITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 54 (± 7 days)

ID	Title	Description
OG000	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.
OG001

Secondary

Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, 48-72 hours

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 14 (± 2 Days)

ID	Title	Description
OG000	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.

Secondary

Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 14 (± 2 Days)

ID	Title	Description
OG000	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.
OG001

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 28 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 28 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	Dalbavancin Two-dose

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 54 (± 7 days)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 54 (± 7 days)

ID	Title	Description
OG000	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.
OG001	Dalbavancin Two-dose

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.

Participants in the microITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, 48-72 hours

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 14 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 28 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with non-missing analysis values at the visit

Posted

Number

percentage of participants

Baseline, Day 54 (± 7 days)

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, 48-72 hours

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 14 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 28 (± 2 Days)

ID	Title	Description
OG000	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.
OG001	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.

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.

Participants in the microITT population with specified baseline pathogen

Posted

Number

percentage of participants

Baseline, Day 54 (± 7 days)

ID	Title	Description
OG000	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.
OG001	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.

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.

All participants in the ITT population

Posted

Count of Participants

Participants

Day 28 (± 2 Days)

ID	Title	Description
OG000	Birth to < 3 Months of Age (Cohort 5)	Participants aged birth to < 3 months

Units	Counts
Participants	OG00010

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.

All participants in the ITT population who received at least 1 dose of study drug with available data

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

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

ID	Title	Description
OG000	Birth to < 3 Months of Age (Cohort 5)	Participants aged birth to < 3 months
OG001	3 Months to < 2 Years Old (Cohort 4)	Participants aged 3 months to < 2 years old
OG002	2 Years to < 6 Years Old (Cohort 3)	Participants aged 2 years to < 6 years old
OG003	Participants Aged 6 Years to < 12 Years Old

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABSCESS BACTERIAL	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected91 at risk EG0010 events0 affected78 at risk EG0020 events0 affected30 at risk
OSTEOMYELITIS BACTERIAL	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected91 at risk EG0010 events0 affected78 at risk EG0020 events0 affected30 at risk
FEBRILE CONVULSION	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected91 at risk EG0010 events0 affected78 at risk EG0020 events0 affected30 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
VOMITING	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected91 at risk EG0012 events2 affected78 at risk EG0020 events0 affected30 at risk
PYREXIA	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected91 at risk EG0012 events2 affected78 at risk EG0020 events0 affected30 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected91 at risk EG0010 events0 affected78 at risk EG0021 events1 affected30 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected91 at risk EG0011 events1 affected78 at risk EG0021 events1 affected30 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected91 at risk EG0012 events2 affected78 at risk EG0020 events0 affected30 at risk

ID	Term
D001424	Bacterial Infections
D013207	Staphylococcal Skin Infections

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D013203	Staphylococcal Infections
D016908	Gram-Positive Bacterial Infections
D017192	Skin Diseases, Bacterial
D012874	Skin Diseases, Infectious
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C469289	dalbavancin
D014640	Vancomycin
D010068	Oxacillin
D005436	Floxacillin
D002434	Cefadroxil
D002981	Clindamycin

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	3	91	1	91
EG001	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	0	78	5	78
EG002	Comparator	Participants 3 months to < 6 years old and ≥6 years to 17 years old (inclusive) who were randomized to the comparator arm received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a total daily dose of 4000 mg; or oxacillin 30 mg/kg/dose or flucloxacillin 50 mg/kg/dose, not to exceed a total daily dose of 2000 mg. Based on local practice patterns and approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. Those on oxacillin or flucloxacillin were permitted to switch to oral cefadroxil (dose for infants and children: 15 mg/kg/dose every 12 hours, maximum 2 g/day; dose for adolescents: 500-1000 mg every 12 hours), and if infection with methicillin-resistant S. aureus was documented, they were allowed to switch from IV vancomycin to oral therapy with clindamycin 10 mg/kg every 8 hours at the discretion of the investigator after at least 72 hours of IV therapy.	30	0	30	1	30

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D010406	Penicillins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003023	Cloxacillin
D002506	Cephalexin
D002511	Cephalosporins
D013843	Thiazines
D008034	Lincomycin
D055231	Lincosamides
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006027	Glycosides