NCT00423657

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 (cSSSI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (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 this 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	ceftaroline	600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
DRUG	vancomycin plus 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	Placebo	Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-01-18
• Last updated: 2017-03-14
• Results posted: 2010-11-18

Locations

54 sites across 12 countries: United States, Argentina, Austria, Brazil, Chile, Germany, Latvia, Mexico, Poland, Russia, Ukraine, United Kingdom