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Completed

NCT Number: NCT01499277

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

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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Key information

Conditions

Complicated Skin and Soft Tissue Infection Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Soft Tissue Infections Suppuration Wound Infection

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Córdoba, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftaroline fosamil

Drug

IV ceftaroline 600mg every 8 hours

Vancomycin

Drug

IV vancomycin 15mg/kg every 12 hours

Aztreonam

Drug

IV aztreonam 1 g every 8 hours

Primary outcomes

  1. Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set

    Time frame: 7 to 20 days after the last dose of study drug

    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.

  2. Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set

    Time frame: 7 to 20 days after the last dose of study drug

    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.

Secondary outcomes

  1. Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set

    Time frame: 7 to 20 days after the last dose of study drug

    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.

  2. Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set

    Time frame: 7 to 20 days after the last dose of study drug

    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.

  3. Clinical Response at End of Treatment (EOT) in MITT Analysis Set

    Time frame: On day of last dose of study drug (or + 1 day)

    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.

  4. Clinical Response at EOT in CE Analysis Set

    Time frame: On day of last dose of study drug (or +1 day)

    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.

  5. Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC

    Time frame: 21 to 42 days after the last dose of study drug

    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.

  6. Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set

    Time frame: 48 to 72 hours after first dose of study drug

    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.

  7. Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME

    Time frame: 7 to 20 days after the last dose of study drug

    Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 26, 2011
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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