Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will
be evaluated in a population of patients with acute bacterial skin and soft tissue infections
(ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and
burn-related infections.

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