Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Abscess; Wound Infection; Surgical Site Infection; Cellulitis
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Cellulitis
Intervention: Dalbavancin; Vancomycin / Linezolid
Intervention description: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8; IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Intervention MeSH terms: Vancomycin; Linezolid; Dalbavancin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 573.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)
      of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral
      linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial
      skin or skin structure infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients 18 - 85 years of age.

          2. Signed and dated informed consent document.

          3. Major abscess, surgical site infection, traumatic wound infection or cellulitis
             suspected or confirmed to be caused by Gram-positive bacteria.

          4. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign
             of infection.

          5. Requires a minimum of 3 days of IV therapy.

          6. Patient willing and able to comply with study procedures.

        Exclusion Criteria:

        Patients presenting with any of the following:

          1. A contra-indication to any required study drug.

          2. Pregnant or nursing females.

          3. Sustained shock.

          4. Participation in another study of an investigational drug or device within 30 days.

          5. Receipt of a systemically or topically administered antibiotic within 14 days prior to
             randomization, except receipt of a single dose of a short-acting antibacterial drug 3
             or more days prior to randomization.

          6. Infection due to a dalbavancin or vancomycin-resistant organism.

          7. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic
             arthritis, osteomyelitis, and/or endovascular infection.

          8. Exclusively gram-negative bacterial or a fungal ABSSSI.

          9. Venous catheter infection.

         10. Infection of a diabetic foot ulcer or a decubitus ulcer.

         11. Device-related infections.

         12. Gram-negative bacteremia.

         13. Infected burns.

         14. Infected limb with critical ischemia.

         15. Superficial/simple skin and skin structure infections.

         16. Concomitant condition requiring non-study antibacterial therapy.

         17. ABSSSI requiring therapy for longer than 14 days.

         18. Adjunctive therapy with hyperbaric oxygen.

         19. More than 2 surgical interventions for ABSSSI anticipated.

         20. Chronic inflammatory condition precluding assessment of clinical response.

         21. Absolute neutrophil count < 500 cells/mm3.

         22. Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3.

         23. Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or
             receiving immunosuppressant drugs after organ transplantation.

         24. Regular, chronic antipyretic use in patients unable to modify during the first three
             days of study drug therapy.

         25. Life expectancy less than 3 months.

         26. Conditions that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results.

         27. Prior participation in the study.