Phase 2
N=150
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
Bacterial Infection
Bottom Line
View on ClinicalTrials.gov: NCT00633152 ↗Enrolled (actual)
150
Serious AEs
2.8%
Results posted
Aug 2012
Primary outcome: Primary: Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population — 84.7; 88.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ceftaroline (Drug); linezolid (Drug); Aztreonam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population |
84.7; 88.9 | — |
| PRIMARY Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population |
90.7; 97.4 | — |
| SECONDARY Clinical Cure Rate at the TOC Visit in the cMITT Population |
— | — |
| SECONDARY Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations. |
— | — |
| SECONDARY The Microbiological Response at the TOC Visit in the mMITT and ME Populations. |
— | — |
| SECONDARY Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations |
— | — |
| SECONDARY Clinical Relapse at the Late Follow-up Visit |
— | — |
| SECONDARY The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit |
— | — |
| SECONDARY The Safety of Ceftaroline Fosamil |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00633152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.