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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01499277
Registration number
NCT01499277
Ethics application status
Date submitted
16/12/2011
Date registered
26/12/2011
Date last updated
6/09/2017
Titles & IDs
Public title
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
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Scientific 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
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Secondary ID [1]
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2011-004013-16
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Secondary ID [2]
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D3720C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Complicated Skin and Soft Tissue Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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0
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ceftaroline fosamil
Treatment: Drugs - Vancomycin
Treatment: Drugs - Aztreonam
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.
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
Treatment: Drugs: Ceftaroline fosamil
IV ceftaroline 600mg every 8 hours
Treatment: Drugs: Vancomycin
IV vancomycin 15mg/kg every 12 hours
Treatment: Drugs: Aztreonam
IV aztreonam 1 g every 8 hours
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
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Assessment method [1]
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The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
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Timepoint [1]
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7 to 20 days after the last dose of study drug
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Primary outcome [2]
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Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
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Assessment method [2]
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The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
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Timepoint [2]
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7 to 20 days after the last dose of study drug
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Secondary outcome [1]
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Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
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Assessment method [1]
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Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
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Timepoint [1]
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7 to 20 days after the last dose of study drug
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Secondary outcome [2]
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Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
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Assessment method [2]
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Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
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Timepoint [2]
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7 to 20 days after the last dose of study drug
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Secondary outcome [3]
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Clinical Response at End of Treatment (EOT) in MITT Analysis Set
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Assessment method [3]
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The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
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Timepoint [3]
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On day of last dose of study drug (or + 1 day)
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Secondary outcome [4]
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Clinical Response at EOT in CE Analysis Set
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Assessment method [4]
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The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
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Timepoint [4]
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On day of last dose of study drug (or +1 day)
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Secondary outcome [5]
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Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
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Assessment method [5]
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The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
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Timepoint [5]
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21 to 42 days after the last dose of study drug
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Secondary outcome [6]
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Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
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Assessment method [6]
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The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
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Timepoint [6]
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48 to 72 hours after first dose of study drug
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Secondary outcome [7]
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Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
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Assessment method [7]
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Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
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Timepoint [7]
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7 to 20 days after the last dose of study drug
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2015
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Sample size
Target
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Accrual to date
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Final
802
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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- Parkville
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Recruitment outside Australia
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California
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Salvador
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Temuco
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Kharkov
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Ukraine
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Odesa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Commercial sector/Industry
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Forest Laboratories
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01499277
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Melnick, MSD
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Address
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01499277
Download to PDF