Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections

Inclusion Criteria:

1. Male or female, 3 months to <12 years of age at randomization

2. Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to becaused 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 2 of the following signs and symptoms:

7. Purulent drainage or discharge

8. Erythema (>1 centimeter 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 1 of the following signs of systemic 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/cubic millimeter [mm^3]) or increasedWBC (>12,000 mm^3)

17. Bandemia >10%

18. C-reactive protein >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. Participants who have received more than 72 hours of effective antibacterial drugtherapy for treatment of the current episode of ABSSSI

2. Participants who have received a glycopeptide antibiotic (for example, vancomycin,telavancin, teicoplanin) within 24 hours of randomization

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

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

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

6. Participants with septic shock or hemodynamic instability

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

8. Infection suspected or documented to be caused predominantly by gram-negativepathogens (for example, 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 (for example, septic arthritis, endocarditis, osteomyelitis). Secondaryinfections due to the same gram-positive bacteria are eligible to be enrolledin this study.

11. Infected burn

12. Primary infection superimposed on a pre-existing skin disease with associatedinflammatory changes (for example, atopic dermatitis, eczema)

13. Any evolving necrotizing process (for example, necrotizing fasciitis),gangrene, or infection suspected or proven to be caused by clostridioidesspecies (for example, crepitance on examination of the ABSSSI site and/orsurrounding tissue[s], radiographic evidence of subcutaneous gas in proximityto the infection)

14. Clinically significant viral infection (for example, influenza, CoronavirusDisease 2019) which, in the investigator's judgement, will impact the studyclinical outcome assessments (for example, participant is febrile due to theviral infection)

15. Participants currently receiving chronic systemic immunosuppressive therapy

16. Participants with neutropenia, defined as absolute neutrophil count <500 cells/mm^3

17. Participants with severe renal impairment, defined as an estimated glomerularfiltration rate <30 milliliters/minute/1.73 meters squared, using the updatedbedside Schwartz formula. For participants under 1 year of age, severe renalimpairment is defined as serum creatinine ≥2 times the 97.5th percentile creatininefor age, converted to mg/deciliter or a requirement for dialysis. Participants under 1 year of age with renal impairment require consultation with the sponsor's medicalmonitor before enrollment.

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

19. Females of childbearing potential (and males with female partners of childbearingpotential) unwilling to practice abstinence or use highly effective methods ofcontraception during the entire study period from the time of the first dose anduntil 50 days after the last dose of protocol-defined study medication. A list ofacceptable methods of contraception is listed in the protocol.

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

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

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

23. Participants whom the investigator considers unlikely to adhere to the protocol,comply with investigational medicinal product (IMP) administration, or complete theclinical study (for example, unlikely to survive 28 days from initiation of IMP)

24. Participants with alanine aminotransferase or aspartate aminotransferase >3* ULN ortotal bilirubin ≥2* ULN