Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)

Exclusion Criteria

• •1. Prior systemic or topical antibacterial therapy with activity against suspected or proven gram-positive pathogens within the preceding 14 days unless:
• •* The causative gram-positive pathogen(s) isolated from the ABSSSI site was/were resistant in vitro to the antibacterial(s) that was/were administered with documented clinical progression.
• •* Documented failure to previous ABSSSI antibiotic therapy was available. Documentation of treatment failure must have been recorded.
• •* Participant received a single dose of a short-acting antibacterial therapy 3 or more days before randomization.
• •2. Infections associated with, or in close proximity to, a prosthetic device
• •3. Severe sepsis or refractory shock
• •4. Known or suspected bacteremia at time of Screening
• •5. ABSSSI due to or associated with any of the following:
• •* Infections suspected or documented to be caused by gram-negative pathogens
• •* Wound infections (surgical or traumatic) and abscesses with only gram-negative pathogens
• •* Diabetic foot infections
• •* Concomitant infection at another site not including a secondary ABSSSI lesion
• •* Infected burns
• •* A primary infection secondary to a pre-existing skin disease with associated inflammatory changes
• •* Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease
• •* Any evolving necrotizing process gangrene or infection suspected or proven to be caused by Clostridium species
• •* Infections known to be caused by a gram-positive organism with a vancomycin minimum inhibitory concentration \>2 micrograms/milliliter or clinically failing prior therapy with glycopeptides
• •* Catheter site infections
• •6. Allergy or intolerance to aztreonam or metronidazole in a participant with suspected or proven polymicrobial wound infection involving gram-negative and/or anaerobic bacteria
• •7. Was currently receiving chronic systemic immunosuppressive therapy
• •8. Acquired immunodeficiency syndrome with cluster of differentiation 4 count \<200 cells/cubic millimeter
• •9. Neutropenia
• •10. Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
• •11. Women who were pregnant or nursing
• •12. History of immune-related hypersensitivity reaction to glycopeptides
• •13. Participants that required anticoagulant monitoring with an activated partial thromboplastin time
• •14. Contraindication to vancomycin
• •15. Participants unwilling to forego blood and/or blood product donation
• •16. Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
• •17. Investigational device present, or removed \<30 days before enrollment, or presence of device-related infection
• •18. Participants unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
• •19. Severe hepatic disease
• •20. Presence of hyperuricemia
• •21. Unwilling to refrain from chronic use of any medication with antipyretic properties