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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00424190Tipo: INTERVENTIONALInicio: 1 de feb de 2007Fin estimado: 1 de nov 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 the 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 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

IV Vancomycin plus IV 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

Ceftaroline

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

Ubicaciones

Investigational Site

Buenos Aires, Argentina

Investigational Site

Buenos Aires, Argentina

Investigational Site

Buenos Aires, Argentina

Invetigational Site

Buenos Aires, Argentina

Investigational Site

Córdoba, Argentina

Invetigational Site

Córdoba, Argentina

Investigational Site

Entre Ríos, Argentina

Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalForest Laboratories

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Multicenter, Randomized, Double-blind, Compara... | EligiMed