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

NCT01499277 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Pfizer
Phase	Phase 3
Status	COMPLETED
Enrolment	802
Start date	2012-05
Completion	2015-01

Conditions

• Complicated Skin and Soft Tissue Infection

Interventions

• Ceftaroline fosamil
• Vancomycin
• Aztreonam

Primary outcomes

• Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set — 7 to 20 days after the last dose of study drug
  The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
• Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set — 7 to 20 days after the last dose of study drug
  The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.

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