NCT00509106

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bacterial Pneumonia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-08-01
• Completion: 2009-06-01
• First posted: 2007-07-31
• Last updated: 2017-03-14
• Results posted: 2010-11-08

Locations

134 sites across 15 countries: United States, Argentina, Austria, Bulgaria, Chile, Germany, Hungary, India, Latvia, Mexico, Peru, Poland, Romania, Russia, Ukraine