NCT00621504

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Detailed description

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

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	IV 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
DRUG	Clarithromycin	In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2009-06-01
• First posted: 2008-02-22
• Last updated: 2017-03-14
• Results posted: 2010-11-10

Locations

168 sites across 23 countries: United States, Argentina, Austria, Brazil, Bulgaria, Estonia, France, Georgia, Germany, Hungary, India, Lithuania, Malaysia, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Ukraine