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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
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.
Details
| Lead sponsor | Forest Laboratories |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 150 |
| Start date | 2008-02 |
| Completion | 2008-07 |
Conditions
- Bacterial Infection
Interventions
- ceftaroline
- linezolid
- Aztreonam
Primary outcomes
- 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.
Countries
United States