A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs 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.

NCT02202135 Phase 3 TERMINATED 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	TERMINATED
Enrolment	4
Start date	2014-06
Completion	2015-01

Conditions

• Complicated Skin and Soft Tissue Infection

Interventions

• Ceftaroline fosamil
• Vancomycin
• Aztreonam

Primary outcomes

• Clinical Response at TOC — 7 to 20 days after last dose of study drug
  Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \>=8 days after the first dose.

Countries

Argentina, Brazil, Bulgaria, Chile, Croatia, Greece, Israel, Italy, Poland, Romania, South Africa, Spain, Turkey (Türkiye)