Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the
Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus
Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue
Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Inclusion Criteria:

- Male or female, aged 18 years or older

- Complicated skin and skin structure infection (cSSTI)

- Infection of sufficient severity to warrant hospitalization

- Infection of sufficient severity such that it is expected to require at least 5 days
of intravenous antibiotic therapy

Exclusion Criteria:

- Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior
to first dose of study drug

- Uncomplicated skin and skin structure infections, skin infections suspected to be
caused by viral or fungal pathogens

- Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease

- Infection caused by human or animal bites, sternal wound infections, bone infection
or arthritis due to an infection, critical limb ischemia of the affected limb

- Chronic liver disease or severe impaired renal function, severe low white blood cell
count, burns on greater than 15% of total body surface area, necrotizing skin
infection, amputation required of primary site of infection, sustained shock