Back to resultsEvaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
Primary Purpose
Complicated Skin and Soft Tissue Infection
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil
Vancomycin
Aztreonam
Sponsored by
About this trial
This is an interventional treatment trial for Complicated Skin and Soft Tissue Infection focused on measuring complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
Eligibility Criteria
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
Sites / Locations
- Research site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ceftaroline fosamil
Vancomycin plus aztreonam
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02202135
First Posted
July 25, 2014
Last Updated
September 1, 2017
Sponsor
Pfizer
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT02202135
Brief Title
Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
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) 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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Overall study status is changed to "Terminated" due to low enrollment
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Forest Laboratories
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Skin and Soft Tissue Infection
Keywords
complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftaroline fosamil
Arm Type
Experimental
Arm Description
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.
Arm Title
Vancomycin plus aztreonam
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil
Intervention Description
IV ceftaroline 600mg every 8 hours
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
IV vancomycin 15mg/kg every 12 hours
Intervention Type
Drug
Intervention Name(s)
Aztreonam
Intervention Description
IV aztreonam 1 g every 8 hours
Primary Outcome Measure Information:
Title
Clinical Response at TOC
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Melnick, MSD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Cordoba
Country
Argentina
Facility Name
Research site
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Research site
City
Passo Fundo
State/Province
Rio Grande do Sul
Country
Brazil
Facility Name
Research site
City
Sao Jose do Rio Preto
Country
Brazil
Facility Name
Research site
City
Pleven
Country
Bulgaria
Facility Name
Research site
City
Temuco
Country
Chile
Facility Name
Research site
City
Zagreb
Country
Croatia
Facility Name
Research site
City
Athens
Country
Greece
Facility Name
Research site
City
Haifa
Country
Israel
Facility Name
Research site
City
Ramat-Gan
Country
Israel
Facility Name
Research site
City
Safed
Country
Israel
Facility Name
Research site
City
Tel-Aviv
Country
Israel
Facility Name
Research site
City
Milano
Country
Italy
Facility Name
Research site
City
Lodz
Country
Poland
Facility Name
Research site
City
Bucharest
Country
Romania
Facility Name
Research site
City
Dundee
Country
South Africa
Facility Name
Research site
City
Worcester
Country
South Africa
Facility Name
Research site
City
Granada
Country
Spain
Facility Name
Research site
City
Terrassa
Country
Spain
Facility Name
Research site
City
Ankara
Country
Turkey
Facility Name
Research site
City
Diyarbakir
Country
Turkey
Facility Name
Research site
City
Izmir
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
27585969
Citation
Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.
Results Reference
derived
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Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
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