Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Study identifier:D3720C00001
ClinicalTrials.gov identifier:NCT01499277
EudraCT identifier:2011-004013-16
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Complicated skin and soft tissue infection
Phase
Phase 3
Healthy volunteers
No
Study drug
Ceftaroline fosamil, Vancomycin, Aztreonam
Sex
All
Actual Enrollment
802
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 01 May 2012
Primary Completion Date: 01 Jun 2014
Study Completion Date: 01 Jan 2015
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Cerexa, Inc.
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
David Melnick
AstraZeneca LP
