Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
- Conditions
- Bacterial Infections
- Interventions
- Registration Number
- NCT00423657
- 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 infections in adults.
- Detailed Description
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 680
- Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.
- Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
- Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftaroline fosamil for Injection Placebo Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. IV Vancomycin plus IV Aztreonam vancomycin plus aztreonam Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours. Ceftaroline fosamil for Injection ceftaroline Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
- Primary Outcome Measures
Name Time Method Clinical Cure Rate at Test of Cure (TOC) (MITT Population) 8-15 days after last dose of study drug administration Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.
Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.
Indeterminate: Inability to determine an outcomeThe Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. 8-15 days after last dose of study drug
- Secondary Outcome Measures
Name Time Method To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit 8-15 days after last dose of study drug To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit 21 to 35 days after the last dose of study drug To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit 21-35 days after last dose of study drug To Evaluate the Clinical Response at the End of Therapy (EOT) Visit last day of study drug administration To Evaluate the Microbiological Success Rate at the TOC Visit 8-15 days after the last dose of study drug To Evaluate Safety first study drug dose through TOC
Trial Locations
- Locations (1)
Investigational Site
🇬🇧London, United Kingdom