Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Complicated Skin and Soft Tissue Infection
About this trial
This is an interventional treatment trial for Complicated Skin and Soft Tissue Infection focused on measuring complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
Eligibility Criteria
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ceftaroline fosamil
Vancomycin plus aztreonam
Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.
Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function