NCT00633152

Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (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 and skin structure infections in adults.

Detailed description

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Conditions

• Bacterial Infection

Interventions

Type	Name	Description
DRUG	ceftaroline	600 mg injected every 12 hours for at least 5 but not more than 14 days
DRUG	linezolid	600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
DRUG	Aztreonam	1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-03-11
• Last updated: 2017-03-14
• Results posted: 2012-08-31

Locations

13 sites across 1 country: United States