A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia

CompletadoFase 3ClinicalTrials.gov

ID: NCT00509106Tipo: INTERVENTIONALInicio: 1 de jul de 2007Fin estimado: 1 de jun de 2009

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Resumen

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Descripción detallada

Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subjects with community-acquired pneumonia requiring:
initial hospitalization or treatment in an emergency room or urgent care setting
infection requiring initial treatment with IV antimicrobial

Criterios de exclusión

Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
Respiratory tract infections not due to community-acquired bacterial pathogens
Infections resistant to ceftriaxone
Any condition requiring concomitant systemic corticosteroids
History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

Intervenciones

drug

Ceftaroline fosamil for Injection

2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days

drug

Ceftriaxone

1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days

drug

Placebo

Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind

Santa Fe, Argentina

Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalForest Laboratories

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