Status:
COMPLETED
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Forest Laboratories
Conditions:
Complicated Skin and Soft Tissue Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
802 Patients enrolled
Trial Details
Trial ID
NCT01499277
Start Date
May 1 2012
End Date
January 1 2015
Last Update
September 6 2017
Active Locations (91)
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1
Research Site
Chula Vista, California, United States
2
Research Site
Orlando, Florida, United States
3
Research Site
West Palm Beach, Florida, United States
4
Research Site
Carmel, Indiana, United States