Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections - Full Text View

Sponsor:	Cerexa, Inc.
Information provided by:	Cerexa, Inc.
ClinicalTrials.gov Identifier:	NCT00633152

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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Linezolid

U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

Evaluate the clinical response of ceftaroline versus linezolid [ Time Frame: Test-of-cure (TOC) visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the clinical response [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate the clinical response [ Time Frame: End-of-therapy (EOT) visit ] [ Designated as safety issue: No ]
Evaluate the microbiological response [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate the clinical response by pathogen [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate clinical relapse [ Time Frame: Late Follow-up (LFU) assessment ] [ Designated as safety issue: No ]
Evaluate the microbiological reinfection or recurrence [ Time Frame: LFU visit ] [ Designated as safety issue: No ]
Evaluate safety [ Time Frame: adverse events (AEs) monitoring throughout the dosing period and up through the TOC visit; serious adverse events (SAEs) are to be recorded through the LFU visit or 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: during study drug administration ] [ Designated as safety issue: No ]

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
A: Experimental ceftaroline	Drug: ceftaroline 600 mg injected every 12 hours for at least 5 but not more than 14 days
B: Active Comparator linezolid	Drug: linezolid 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days (with or without aztreonam)

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

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

Locations

United States, California
Investigational Site
Los Angeles, California, United States, 90015
Investigational Site
San Diego, California, United States, 92114
Investigational Site
Rolling Hills Estate, California, United States, 90274
Investigational Site
Buena Park, California, United States, 96020
Investigational Site
Long Beach, California, United States, 90813
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. ( Senior Vice President, Clinical Development )
Study ID Numbers:	P903-19
Study First Received:	March 3, 2008
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00633152 History of Changes
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
Protein Synthesis Inhibitors
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010