Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Skin and Subcutaneous Tissue Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: Delafloxacin; Vancomycin; Aztreonam; Placebo
Intervention description: Delafloxacin; Vancomycin; Aztreonam; Placebo
Intervention MeSH terms: Vancomycin; Aztreonam; Delafloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bacterial skin infection; skin infection; infection; skin; delafloxacin; vancomycin; aztreonam; MRSA bacteria; bacterial infection; Anti-Infective Agents; Anti-Bacterial Agents

Summary:

      This study was designed to evaluate the efficacy of delafloxacin patients with acute
      bacterial skin and soft tissue infections (ABSSSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years of age) men or women with a diagnosis of Acute Bacterial Skin and
             Skin Structure Infections (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 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:

               1. Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is
                  documented (i.e., not by patient history alone).

               2. 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.

               3. 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