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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00633152
First received: March 3, 2008
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Bacterial Infection
Drug: ceftaroline
Drug: linezolid
Drug: Aztreonam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Clinical Cure Rate at the TOC Visit in the cMITT Population [ Time Frame: TOC Visit (8 to 15 days after end of therapy) ] [ Designated as safety issue: No ]
    Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.

  • Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations. [ Time Frame: End-of-therapy (EOT) visit ] [ Designated as safety issue: No ]
    Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.

  • 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) ] [ Designated as safety issue: No ]
    Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.

  • 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) ] [ Designated as safety issue: No ]
    Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.

  • Clinical Relapse at the Late Follow-up Visit [ Time Frame: Late Follow-up (LFU) Visit (21 to 35 days after end of therapy) ] [ Designated as safety issue: No ]
    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.

  • The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit [ Time Frame: LFU Visit (21 to 35 days after end of therapy) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    Evaluate safety of Ceftaroline fosamil IM in adults with cSSSI


Enrollment: 150
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftaroline
Intramuscular every 12 hours
Drug: ceftaroline
600 mg injected every 12 hours for at least 5 but not more than 14 days
Other Names:
  • ceftaroline fosamil
  • ceftaroline for injection
Active Comparator: linezolid plus optional aztreonam
Intravenous every 12 hours
Drug: linezolid
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
Drug: Aztreonam
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633152

Locations
United States, California
Investigational Site
Buena Park, California, United States, 96020
Investigational Site
Long Beach, California, United States, 90813
Investigational Site
Los Angeles, California, United States, 90015
Investigational Site
Rolling Hills Estate, California, United States, 90274
Investigational Site
San Diego, California, United States, 92114
United States, Florida
Investigational Site
Atlantis, Florida, United States, 33462
United States, Georgia
Investigational Site
Columbus, Georgia, United States, 31904
Investigational Site
Savannah, Georgia, United States, 31405
United States, Minnesota
Investigational Site
Minneapolis, Minnesota, United States, 55422
United States, Montana
Investigational Site
Butte, Montana, United States, 59701
United States, New Jersey
Investigational Site
Somers Point, New Jersey, United States, 08244
United States, Ohio
Investigational Site
Columbus, Ohio, United States, 43215
Investigational Site
Toledo, Ohio, United States, 43608
Sponsors and Collaborators
Cerexa, Inc.
Investigators
Study Director: Medical Monitor Cerexa Cerexa, Inc.
  More Information

No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT00633152     History of Changes
Other Study ID Numbers: P903-19
Study First Received: March 3, 2008
Results First Received: July 25, 2012
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Cerexa, Inc.:
complicated skin and skin structure infections
linezolid
ceftaroline
clinical response
microbiological response
Cellulitis
Abscess
Wound infection
Deeper soft tissue
Significant surgical intervention
Gram-positive bacterial infection
Gram-negative bacterial infection
bacterial infection
cephalosporin
broad-spectrum activity

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection
Aztreonam
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014