Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Inclusion Criteria:

1. Male or female, 3 months to <18 years of age at randomization

2. Diagnosis of at least one of the following ABSSSI infections (known or suspected tobe caused by a gram-positive pathogen):

3. Wound infection: that is either traumatic or surgical in origin, defined as aninfection characterized by purulent drainage from a wound with surroundingerythema, edema, and/or induration

4. Cellulitis/erysipelas: a diffuse skin infection characterized by spreadingareas of erythema, edema, and/or induration

5. Major cutaneous abscess: an infection characterized by a collection of puswithin the dermis or subcutaneous tissue that is accompanied by surroundingerythema, edema, and/or induration

6. ABSSSI must present with at least two of the following signs and symptoms:

7. Purulent drainage or discharge

8. Erythema (>1 cm beyond edge of wound or abscess)

9. Fluctuance

10. Heat or localized warmth

11. Edema/induration

12. Pain or tenderness to palpation AND at least one of the following signs ofsystemic inflammation:

13. Proximal lymph node swelling and tenderness

14. Increased temperature (>38.0°C [>100.4°F])

15. Decreased temperature (<36.0°C [<96.8°F])

16. Decreased white blood count (WBC) (<4000/mm3) or increased WBC (>12,000mm3)

17. Bandemia >10%

18. C-reactive protein (CRP) >upper limit of normal (ULN)

19. Written informed consent obtained from parent(s) or legal guardian(s), with writtenor documented verbal assent of the child obtained, when appropriate, beforeinitiation of any assessments conducted solely for study purposes.

Exclusion Criteria:

1. Subjects who have received more than 72 hours of effective antibacterial drugtherapy for treatment of the current episode of ABSSSI

2. Subjects who have received a glycopeptide antibiotic (e.g., vancomycin, telavancin,teicoplanin) within 24 hours of randomization

3. Subjects who have received dalbavancin within 45 days prior to randomization

4. Subjects who have been treated with oritavancin within the last 50 days

5. Subjects with infection suspected to be associated with a device or implant

6. Subjects with septic shock or hemodynamic instability

7. Subjects with ABSSSI due to, or associated with any of the following:

8. Infection suspected or documented to be caused solely by gram-negativepathogens (e.g., human or animal bite, injury contaminated with fresh orsaltwater, external malignant otitis), fungi, or viruses

9. Wound infection (surgical or traumatic) or abscess with only gram-negativepathogens

10. Concomitant infection at another site, not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis).

11. Infected burn

12. Primary infection superimposed on a pre-existing skin disease with associatedinflammatory changes, e.g., atopic dermatitis, eczema

13. Any evolving necrotizing process (e.g., necrotizing fasciitis), gangrene, orinfection suspected or proven to be caused by clostridioides species (e.g.,crepitance on examination of the ABSSSI site and/or surrounding tissue(s),radiographic evidence of subcutaneous gas in proximity to the infection)

14. Clinically significant viral infection (e.g., influenza, COVID-19) which, inthe Investigator's judgement, will impact the study clinical outcomeassessments (e.g., subject is febrile due to the viral infection)

15. Subjects currently receiving chronic systemic immunosuppressive therapy

16. Subjects with neutropenia, defined as absolute neutrophil count (ANC) <500 cells/mm3

17. Creatinine clearance (CrCl) < 30 mL/min/1.73 m2 as calculated using the updatedSchwartz bedside formula: eGFR = k x (height in cm) ÷ serum Creatinine k = 0.33 in pre-term infants. k = 0.45in term infants to 1 year of age. k = 0.55 in children and adolescent girls. k = 0.70 in adolescent boys

18. Menstruating females with a positive result for the urine or serum human chorionicgonadotropin (HCG) test administered at screening

19. Females of childbearing potential (and males with female partners of childbearingpotential) unwilling to practice abstinence or use at least two methods ofcontraception (e.g., oral contraceptives, barrier methods, approved contraceptiveimplants) during the entire study period

20. Subjects with a history of infusion-related immunoglobulin E (IgE)-mediated allergicreaction or hypersensitivity reaction to glycopeptides (e.g., vancomycin,telavancin, dalbavancin, oritavancin, teicoplanin) or any of their excipients

21. Subjects who are taking heparin (other than heparin flush for line patency) orwarfarin, and/or require anticoagulant monitoring [activated partial thromboplastintime (aPTT), prothrombin time (PT), international normalized ratio (INR)]

22. Subjects receiving treatment with an investigational medicinal product orinvestigational device within 3 months before enrollment or during the study

23. Subjects whom the investigator considers unlikely to adhere to the protocol, complywith Study Drug administration, or complete the clinical study (e.g., unlikely tosurvive 28 days from initiation of Study Drug)

24. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3xULN or total bilirubin ≥2x ULN.