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Completed

NCT Number: NCT00633152

Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

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Key information

Conditions

Bacterial Infection Abscess Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site, Buena Park, California, United States

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About this study

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Complicated skin and skin structure infection (cSSSI)
  • Require initial hospitalization, or treatment in an emergency room or urgent care setting

Exclusion criteria

  • Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
  • Concomitant use of adrenergic or serotonergic agent
  • Uncomplicated skin and skin structure infection
  • Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
  • More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
  • Known or suspected endocarditis, osteomyelitis, or septic arthritis
  • Severely impaired renal function
  • Evidence of significant hepatic, hematologic, or immunologic disease

Treatment and study plan

ceftaroline

Drug

600 mg injected every 12 hours for at least 5 but not more than 14 days

Other names: ceftaroline fosamil, ceftaroline for injection

Linezolid

Drug

600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days

Other names: Zyvox, Zyvoxid, CAS number 165800-03-3

Aztreonam

Drug

1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.

Primary outcomes

  1. Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population

    Time frame: Test of Cure Visit (8 to 15 days after end of therapy)

    The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

  2. Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population

    Time frame: Test of Cure Visit (8 to 15 Days after end of therapy)

    The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.

Secondary outcomes

  1. Clinical Cure Rate at the TOC Visit in the cMITT Population

    Time frame: TOC Visit (8 to 15 days after end of therapy)

    Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.

  2. Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.

    Time frame: End-of-therapy (EOT) visit

    Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.

  3. The Microbiological Response at the TOC Visit in the mMITT and ME Populations.

    Time frame: TOC Visit (8 to 15 days after end of therapy)

    Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.

  4. Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations

    Time frame: TOC Visit (8 to 15 days after end of therapy)

    Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.

  5. Clinical Relapse at the Late Follow-up Visit

    Time frame: Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)

    Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.

  6. The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit

    Time frame: LFU Visit (21 to 35 days after end of therapy)

    Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.

  7. The Safety of Ceftaroline Fosamil

    Time frame: First dose of study drug through LFU Visit or 30 days after the last dose of study drug

    Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 11, 2008
Registry last updated
Mar 14, 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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