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

Bacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633152
• Other study ID #: P903-19
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2008
• Last updated: October 9, 2012
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: October 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Infection

Intervention

Drug:
• ceftaroline
600 mg injected every 12 hours for at least 5 but not more than 14 days
• linezolid
600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
• 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.

Locations

Country	Name	City	State
United States	Investigational Site	Atlantis	Florida
United States	Investigational Site	Buena Park	California
United States	Investigational Site	Butte	Montana
United States	Investigational Site	Columbus	Georgia
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Long Beach	California
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	Minneapolis	Minnesota
United States	Investigational Site	Rolling Hills Estate	California
United States	Investigational Site	San Diego	California
United States	Investigational Site	Savannah	Georgia
United States	Investigational Site	Somers Point	New Jersey
United States	Investigational Site	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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.	TOC Visit (8 to 15 days after end of therapy)	No
Secondary	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.	End-of-therapy (EOT) visit	No
Secondary	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.	TOC Visit (8 to 15 days after end of therapy)	No
Secondary	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.	TOC Visit (8 to 15 days after end of therapy)	No
Secondary	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.	Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)	No
Secondary	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.	LFU Visit (21 to 35 days after end of therapy)	No
Secondary	The Safety of Ceftaroline Fosamil	Evaluate safety of Ceftaroline fosamil IM in adults with cSSSI	First dose of study drug through LFU Visit or 30 days after the last dose of study drug	Yes