Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
Condition: Wound Infection; Abscess; Systemic Inflammation; Cellulitis
MeSH terms: Infections; Communicable Diseases; Wound Infection; Abscess; Cellulitis; Inflammation
Intervention: Single-Dose IV Oritavancin Diphosphate; IV Vancomycin; Placebo
Intervention description: Oritavancin was administered as a single IV dose.; Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days.; Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo).
Intervention MeSH terms: Vancomycin; Oritavancin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 968.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABSSSI; Skin Infection; Abscess

Summary:

      The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of
      oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those
      caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential
      economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV)
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants were included in the study if they met all of the following inclusion
        criteria:

          1. Males or females ≥18 years old

          2. Diagnosis of ABSSSI suspected or confirmed to be caused by a gram-positive pathogen
             requiring at least 7 days of IV therapy

          3. An ABSSSI included 1 of the following infections: wound infections,
             cellulitis/erysipelas, major cutaneous abscess

          4. ABSSSI must have presented with at least 2 local signs and symptoms and at least 1
             sign of systemic inflammation (unless >70 years of age).

          5. Able to give informed consent and willing to comply with all required study procedures

        Exclusion Criteria:

        Participants were excluded from the study if any of the following exclusion criteria
        applied prior to randomization:

          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