At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 802 enrolled
Drug / intervention
Ceftaroline fosamil +2 moredrug
Likely dose
Ceftaroline fosamil 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ceftaroline fosamil, Vancomycin, and 1 other intervention for Complicated Skin and Soft Tissue Infection. Completed, enrolled 802 participants across 91 sites in 28 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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, United States
CollaboratorsForest Laboratories
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMay 2012
Primary CompletionJun 2014
Study CompletionJan 2015
TodayJul 2026
First PostedDec 26, 2011
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.5 years ago
Interventions
Ceftaroline fosamildrug
IV ceftaroline 600mg every 8 hours
Vancomycindrug
IV vancomycin 15mg/kg every 12 hours
Aztreonamdrug
IV aztreonam 1 g every 8 hours