NCT01499277

Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 802 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

Detailed description

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Conditions

• Complicated Skin and Soft Tissue Infection

Interventions

Type	Name	Description
DRUG	Ceftaroline fosamil	IV ceftaroline 600mg every 8 hours
DRUG	Vancomycin	IV vancomycin 15mg/kg every 12 hours
DRUG	Aztreonam	IV aztreonam 1 g every 8 hours

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-06-01
• Completion: 2015-01-01
• First posted: 2011-12-26
• Last updated: 2017-09-06
• Results posted: 2015-11-09

Locations

91 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Croatia, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine