At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 698 enrolled
Drug / intervention
IV Vancomycin plus IV Aztreonam +1 moredrug
Likely dose
IV Vancomycin plus IV Aztreonam 1 gfrom 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 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection
In Brief
A Phase 3 clinical trial evaluating IV Vancomycin plus IV Aztreonam and Ceftaroline for Bacterial Infections. Completed, enrolled 698 participants across 52 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Infections
CountriesArgentina, Brazil, Chile, Germany, Mexico, Peru, Poland, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartFeb 2007
Primary CompletionNov 2007
TodayJul 2026
First PostedJan 18, 2007
Enrollment StartFeb 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.5 years ago
Interventions
IV Vancomycin plus IV Aztreonamdrug
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
Ceftarolinedrug
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days