A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00423657Tipo: INTERVENTIONALInicio: 1 de mar de 2007Fin estimado: 1 de dic de 2007

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Descripción detallada

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

ceftaroline

600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

drug

vancomycin plus aztreonam

vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.

drug

Placebo

Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Ubicaciones

Investigational Site

Buenos Aires, Argentina

Investigational Site

Córdoba, Argentina

Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalForest Laboratories

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