Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Skin and Subcutaneous Tissue Bacterial Infections; Skin Structures and Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections
Intervention: delafloxacin; vancomycin; aztreonam
Intervention MeSH terms: Vancomycin; Aztreonam; Delafloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 850.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bacterial skin infection; infection; skin; delafloxacin; vancomycin; aztreonam; methicillin-resistant Staphylococcus aureus (MRSA) bacteria; bacterial infection; Anti-Infective Agents

Summary:

      The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus
      Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI
             (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection)
             with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs
             of systemic infection

          -  In the opinion of the investigator, the subject must require and be a suitable
             candidate for IV antibiotic therapy, and the subject must be able and willing to
             comply with protocol requirements

        Exclusion Criteria:

          -  A medical history of significant hypersensitivity or allergic reaction to quinolones,
             beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the
             investigator.

          -  Women who are pregnant or lactating.

          -  Any chronic or underlying skin condition at the site of infection that may complicate
             the assessment of response, including infection involving a prosthetic joint, human or
             animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis,
             mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing
             cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas
             gangrene; burns covering ≥10% of body surface area; severely compromised immune
             system, severely impaired arterial blood supply to an extremity with an ABSSSI, deep
             vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or
             multiple debridement procedures.

          -  Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of
             the following was documented:

               -  Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is
                  documented (i.e., not by patient history alone).

               -  Recently (within 14 days) completed a treatment course with an antibacterial drug
                  for an infection other than ABSSSI and the drug does not have activity against
                  bacterial pathogens that cause ABSSSI.

               -  Received only 1 dose of either a single, potentially effective, short-acting
                  antimicrobial drug or drug regimen for ABSSSI.

          -  Any underlying disease that, in the opinion of the investigator, could interfere with
             the subject's ability to participate in the study including severe cardiac disease,
             known history of liver disease, end-stage renal disease, malignancy, psychiatric
             disorder, ongoing treatment for seizures or untreated history of seizures, or life
             expectancy of < 3 months.