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

Completed · Phase 3

Conditions studied: Complicated Skin and Soft Tissue Infection

In brief

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

Key facts

Study ID

NCT01499277

Run by

Pfizer

People needed

802

Starts

2012-05-01

Expected to finish

2015-01-01

Last updated by the study team

2017-09-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Orlando, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Carmel, Indiana, United States
• Research Site — Hazard, Kentucky, United States
• Research Site — Springfield, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Garden City, New York, United States
• Research Site — Bellaire, Texas, United States
• Research Site — Córdoba, Argentina
• Research Site — Santa Fe, Argentina
• Research Site — Parkville, Australia
• Research Site — Brussels, Belgium
• Research Site — Belo Horizonte, Brazil
• Research Site — Passo Fundo, Brazil
• Research Site — Salvador, Brazil
• Research Site — São José do Rio Preto, Brazil
• Research Site — Pleven, Bulgaria
• Research Site — Rousse, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Temuco, Chile
• Research Site — Viña del Mar, Chile
• Research Site — Beijing, China
• Research Site — Changchun, China
• Research Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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