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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
IV ceftaroline 600mg every 8 hours
IV vancomycin 15mg/kg every 12 hours
IV aztreonam 1 g every 8 hours
Research site
Córdoba, Argentina
Research site
Salvador, Estado de Bahia, Brazil
Clinical Response at TOC
Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \>=8 days after the first dose.
Time frame: 7 to 20 days after last dose of study drug
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Research site
Passo Fundo, Rio Grande do Sul, Brazil
Research site
São José do Rio Preto, Brazil
Research site
Pleven, Bulgaria
Research site
Temuco, Chile
Research site
Zagreb, Croatia
Research site
Athens, Greece
Research site
Haifa, Israel
Research site
Ramat Gan, Israel
...and 12 more locations