Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
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
Intervention description: Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.; Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
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: 1019.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABSSSI; Skin Infection; Abscess

Summary:

      The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of
      oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic
      benefit of oritavancin administered as a single 1200 mg IV dose.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects may be included in the study if they meet 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 5 days of IV therapy

          3. An ABSSSI includes one of the following infections Wound infections,
             Cellulitis/erysipelas, Major cutaneous abscess

          4. ABSSSI must present with at least 2 signs and symptoms

          5. Able to give informed consent and willing to comply with all required study procedures

        Exclusion Criteria:

        Subjects will be excluded from the study if any of the following exclusion criteria apply
        prior to randomization:

          1. Prior systemic or topical antibacterial therapy with activity against suspected or
             proven Gram-positive pathogens within the preceding 14 days

               -  The causative Gram-positive pathogen(s) isolated from the ABSSSI site is
                  resistant in vitro to the antibacterial(s) that was administered with documented
                  clinical progression, or

               -  Documented failure to previous ABSSSI antibiotic therapy is available.
                  Documentation of treatment failure must be recorded

               -  Patient received a single dose of a short acting antibacterial therapy three 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 MIC
                  >2 μg/mL or clinically failing prior therapy with glycopeptides

               -  Catheter site infections

          6. Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or
             proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria

          7. Currently receiving chronic systemic immunosuppressive therapy

          8. AIDS with CD4 count < 200 cells/mm3

          9. Neutropenia

         10. Significant or life-threatening condition that would confound or interfere with the
             assessment of the ABSSSI

         11. Women who are pregnant or nursing

         12. History of immune-related hypersensitivity reaction to glycopeptides

         13. Patients that require anticoagulant monitoring with an aPTT

         14. Contraindication to vancomycin

         15. Patients 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. Patients 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