Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
- Conditions
- Bacterial Infection
- Interventions
- Registration Number
- NCT00633152
- Lead Sponsor
- Forest Laboratories
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Complicated skin and skin structure infection (cSSSI)
- Require initial hospitalization, or treatment in an emergency room or urgent care setting
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description linezolid plus optional aztreonam Aztreonam Intravenous every 12 hours linezolid plus optional aztreonam linezolid Intravenous every 12 hours Ceftaroline ceftaroline Intramuscular every 12 hours
- Primary Outcome Measures
Name Time Method Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population Test of Cure Visit (8 to 15 days after end of therapy) 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 Test of Cure Visit (8 to 15 Days after end of therapy) 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
Name Time Method Clinical Cure Rate at the TOC Visit in the cMITT Population TOC Visit (8 to 15 days after end of therapy) 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. End-of-therapy (EOT) visit 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. TOC Visit (8 to 15 days after end of therapy) 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 TOC Visit (8 to 15 days after end of therapy) 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 Late Follow-up (LFU) Visit (21 to 35 days after end of therapy) 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 LFU Visit (21 to 35 days after end of therapy) 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 First dose of study drug through LFU Visit or 30 days after the last dose of study drug Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)
Trial Locations
- Locations (1)
Investigational Site
🇺🇸Toledo, Ohio, United States