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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Research Site
Chula Vista, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Skin and Soft Tissue Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01499277
Pfizer
Completed
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin 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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Complicated Skin and Soft Tissue Infection
  • Drug: Ceftaroline fosamil
    IV ceftaroline 600mg every 8 hours
  • Drug: Vancomycin
    IV vancomycin 15mg/kg every 12 hours
  • Drug: Aztreonam
    IV aztreonam 1 g every 8 hours
  • 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.
    Intervention: Drug: Ceftaroline fosamil
  • 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
    Interventions:
    • Drug: Vancomycin
    • Drug: Aztreonam
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. Epub 2016 Sep 1.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
802
January 2015
June 2014   (Final data collection date for primary outcome measure)

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

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Chile,   China,   Croatia,   Czechia,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Austria,   Colombia,   Czech Republic,   Hungary,   India,   Slovakia,   Thailand,   United Kingdom
 
NCT01499277
D3720C00001
2011-004013-16
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Forest Laboratories
Study Director: David Melnick, MSD AstraZeneca
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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