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

NCT00633152 | Completed Phase 2 Results

• 1 other identifier: P903-19
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Bacterial Infection

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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.

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

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

  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.

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

Secondary Outcomes (7)

• Clinical Cure Rate at the TOC Visit in the cMITT Population

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

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

  End-of-therapy (EOT) visit

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

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

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

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

• Clinical Relapse at the Late Follow-up Visit

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

Study Arms (2)

Ceftaroline

EXPERIMENTAL

Intramuscular every 12 hours

Drug: ceftaroline

linezolid plus optional aztreonam

ACTIVE COMPARATOR

Intravenous every 12 hours

Drug: linezolid; Drug: Aztreonam

Interventions

ceftaroline DRUG

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

Also known as: ceftaroline fosamil, ceftaroline for injection

Ceftaroline

linezolid DRUG

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

Also known as: Zyvox, Zyvoxid, CAS number 165800-03-3

linezolid plus optional aztreonam

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.

linezolid plus optional aztreonam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (13)

Investigational Site

Buena Park, California, 96020, United States

Location

Investigational Site

Long Beach, California, 90813, United States

Location

Investigational Site

Los Angeles, California, 90015, United States

Location

Investigational Site

Rolling Hills Estate, California, 90274, United States

Location

Investigational Site

San Diego, California, 92114, United States

Location

Investigational Site

Atlantis, Florida, 33462, United States

Location

Investigational Site

Columbus, Georgia, 31904, United States

Location

Investigational Site

Savannah, Georgia, 31405, United States

Location

Investigational Site

Minneapolis, Minnesota, 55422, United States

Location

Investigational Site

Butte, Montana, 59701, United States

Location

Investigational Site

Somers Point, New Jersey, 08244, United States

Location

Investigational Site

Columbus, Ohio, 43215, United States

Location

Investigational Site

Toledo, Ohio, 43608, United States

Location

MeSH Terms

Conditions

Bacterial Infections; Cellulitis; Abscess; Wound Infection; Gram-Positive Bacterial Infections; Gram-Negative Bacterial Infections

Interventions

Ceftaroline; Injections; Linezolid; Aztreonam

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Monobactams

Results Point of Contact

• Title: Vice President, Clinical Sciences
• Organization: Cerexa, Inc.

clinicaltrials@cerexa.com

510-285-9200

Study Officials

• Medical Monitor Cerexa

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 11, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 14, 2017
• Results First Posted: August 31, 2012

Record last verified: 2017-02

Locations

US (13)