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

Primary Purpose

Bacterial Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ceftaroline
linezolid
Aztreonam
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infection focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline

linezolid plus optional aztreonam

Arm Description

Intramuscular every 12 hours

Intravenous every 12 hours

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Clinical Cure Rate at the TOC Visit in the cMITT Population
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.
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.
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
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
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
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
Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)

Full Information

First Posted
March 3, 2008
Last Updated
February 2, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00633152
Brief Title
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline
Arm Type
Experimental
Arm Description
Intramuscular every 12 hours
Arm Title
linezolid plus optional aztreonam
Arm Type
Active Comparator
Arm Description
Intravenous every 12 hours
Intervention Type
Drug
Intervention Name(s)
ceftaroline
Other Intervention Name(s)
ceftaroline fosamil, ceftaroline for injection
Intervention Description
600 mg injected every 12 hours for at least 5 but not more than 14 days
Intervention Type
Drug
Intervention Name(s)
linezolid
Other Intervention Name(s)
Zyvox, Zyvoxid, CAS number 165800-03-3
Intervention Description
600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
Intervention Type
Drug
Intervention Name(s)
Aztreonam
Intervention Description
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 Outcome Measure Information:
Title
Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population
Description
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.
Time Frame
Test of Cure Visit (8 to 15 days after end of therapy)
Title
Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
Description
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.
Time Frame
Test of Cure Visit (8 to 15 Days after end of therapy)
Secondary Outcome Measure Information:
Title
Clinical Cure Rate at the TOC Visit in the cMITT Population
Description
Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.
Time Frame
TOC Visit (8 to 15 days after end of therapy)
Title
Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.
Description
Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.
Time Frame
End-of-therapy (EOT) visit
Title
The Microbiological Response at the TOC Visit in the mMITT and ME Populations.
Description
Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.
Time Frame
TOC Visit (8 to 15 days after end of therapy)
Title
Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations
Description
Evaluate the 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)
Title
Clinical Relapse at the Late Follow-up Visit
Description
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.
Time Frame
Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)
Title
The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit
Description
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.
Time Frame
LFU Visit (21 to 35 days after end of therapy)
Title
The Safety of Ceftaroline Fosamil
Description
Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)
Time Frame
First dose of study drug through LFU Visit or 30 days after the last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor Cerexa
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Buena Park
State/Province
California
ZIP/Postal Code
96020
Country
United States
Facility Name
Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Investigational Site
City
Rolling Hills Estate
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Investigational Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Investigational Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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