NCT00424190

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (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 complicated skin infections in adults.

Detailed description

Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-01-18
• Last updated: 2017-03-14
• Results posted: 2010-11-08

Locations

52 sites across 11 countries: United States, Argentina, Brazil, Chile, Germany, Mexico, Peru, Poland, Romania, Russia, Ukraine