- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202135
Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
September 1, 2017 updated by: Pfizer
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.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cordoba, Argentina
- Research Site
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Sao Jose do Rio Preto, Brazil
- Research Site
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Bahia
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Salvador, Bahia, Brazil
- Research Site
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, Brazil
- Research Site
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Pleven, Bulgaria
- Research Site
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Temuco, Chile
- Research Site
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Zagreb, Croatia
- Research Site
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Athens, Greece
- Research Site
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Haifa, Israel
- Research Site
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Ramat-Gan, Israel
- Research Site
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Safed, Israel
- Research Site
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Tel-Aviv, Israel
- Research Site
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Milano, Italy
- Research Site
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Lodz, Poland
- Research Site
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Bucharest, Romania
- Research Site
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Dundee, South Africa
- Research Site
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Worcester, South Africa
- Research Site
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Granada, Spain
- Research Site
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Terrassa, Spain
- Research Site
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Ankara, Turkey
- Research Site
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Diyarbakir, Turkey
- Research Site
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Izmir, Turkey
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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IV ceftaroline 600mg every 8 hours
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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
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IV vancomycin 15mg/kg every 12 hours
IV aztreonam 1 g every 8 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical Response at TOC
Time Frame: 7 to 20 days after last dose of study drug
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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.
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7 to 20 days after last dose of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: David Melnick, MSD, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
July 25, 2014
First Submitted That Met QC Criteria
July 25, 2014
First Posted (Estimate)
July 28, 2014
Study Record Updates
Last Update Posted (Actual)
September 6, 2017
Last Update Submitted That Met QC Criteria
September 1, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3720C00001sub
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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