Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

Forest Laboratories622 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

622

Conditions

Bacterial Pneumonia

Interventions

Ceftaroline fosamil for InjectionDRUG

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

CeftriaxoneDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: * 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

Locations (134)

Outcomes

Primary Outcomes

Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population

Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: * Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy * Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia * Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome