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

This study has been completed.
Sponsor:
Collaborator:
Cerexa, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499277
First received: December 16, 2011
Last updated: July 25, 2014
Last verified: July 2014

December 16, 2011
July 25, 2014
May 2012
June 2014   (final data collection date for primary outcome measure)
Clinical Cure as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in both the modified Intent-To-Treat and the Clinically Evaluable analysis sets [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01499277 on ClinicalTrials.gov Archive Site
  • The clinical cure rate in the modified intent-to-treat and clinically evaluable analysis sets [ Time Frame: within 24 hours of completion of last infusion of study drug ] [ Designated as safety issue: No ]
  • The per-patient microbiological favorable response in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets [ Time Frame: within 24 hours of completion of the last infusion of study drug and 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • The clinical cure rate and per-pathogen microbiological favorable response by baseline pathogen in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical relapse in patients who were clinically cured at the test of cure visit in the clinically evaluable analysis set [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Re-infection and recurrence rate in patients who were microbiological successes at the test of cure visits in the microbiologically evaluable analysis set [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Super-infection rate in the microbiologically evaluable analysis set [ Time Frame: within 24 hours of completion of the last infusion of study drug ] [ Designated as safety issue: No ]
  • New infection rate in the microbiologically evaluable analysis set [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Colonization rate in patients who had a clinical assessment in the microbiologically evaluable analysis set [ Time Frame: within 24 hours of completion of the last infusion of study drug or 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Early response rate in the modified intent-to-treat and clinically evaluable analysis sets [ Time Frame: at 48 to 72 hours of treatment ] [ Designated as safety issue: No ]
  • The safety and tolerability by incidence and severity of adverse events, vital signs, clinical laboratory tests, ECGs and physical exam [ Time Frame: study duration (26 days up to 51 days) ] [ Designated as safety issue: Yes ]
  • Description of population pharmacokinetics of ceftaroline and ceftaroline fosamil in this patient population. [ Time Frame: Within 15 minutes prior to start of infusion, 120 min +/- 5 min following start of infusion through end of infusion, 3-5 hours after start of infusion, and 6-8 hours after start of study drug and prior to next infusion ] [ Designated as safety issue: No ]
  • PK profiles, including Cmax, Tmax, t½λz, AUC, plasma clearance, Vz, Vss, and mean residence time, of ceftaroline, ceftaroline fosamil and ceftaroline M-1 with intensive sampling in a subset of about 45 patients [ Time Frame: Within 15 minutes prior to start of infusion and following the start of infusion at 60, 90, 115, 125, 135 minutes and 2.5, 3, 4, 5, 6, and 8 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
801
June 2014
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Chile,   China,   Croatia,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   Ukraine
 
NCT01499277
D3720C00001, 2011-004013-16
Not Provided
AstraZeneca
AstraZeneca
Cerexa, Inc.
Study Director: David Melnick, MSD AstraZeneca
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP