Study identifier:D3720C00001sub
ClinicalTrials.gov identifier:NCT02202135
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) vs 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.
Complicated skin and soft tissue infection
Phase 3
No
Ceftaroline fosamil, Vancomycin, Aztreonam
All
4
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2016 by AstraZeneca
AstraZeneca
Cerexa, Inc.
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
Location
Location
Cordoba, Argentina
Location
Salvador, Bahia, Brazil
Location
Sao Jose do Rio Preto, Brazil
Location
Passo Fundo, Rio Grande Do Sul, Brazil
Location
Pleven, Bulgaria
Location
Temuco, Chile
Location
Zagreb, Croatia
Location
Athens, Greece
Arms | Assigned Interventions |
---|---|
Experimental: Ceftaroline fosamil 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. | Drug: Ceftaroline fosamil IV ceftaroline 600mg every 8 hours |
Active Comparator: Vancomycin plus aztreonam 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 | Drug: Vancomycin IV vancomycin 15mg/kg every 12 hours Drug: Aztreonam IV aztreonam 1 g every 8 hours |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.