The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus
Aztreonam in the treatment of patients with complicated bacterial and soft tissue
infections.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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
- 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
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