At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 680 enrolled

Drug / intervention

ceftaroline +2 moredrug

Likely dose

ceftaroline 600 mgfrom 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.

Search/NCT00423657

NCT00423657Phase 3Completed

Compare CT.gov

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 (cSSSI)

Forest Laboratories·interventional·Posted Jan 18, 2007·Updated Mar 14, 2017

In Brief

A Phase 3 clinical trial evaluating ceftaroline, vancomycin plus aztreonam, and 1 other intervention for Bacterial Infections. Completed, enrolled 680 participants across 54 sites in 12 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, Austria, Brazil, Chile, Germany, Latvia, Mexico, Poland, Russia, Ukraine, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedJan 2007

Enrollment StartMar 2007

Primary CompletionDec 2007

TodayJul 2026

First PostedJan 18, 2007

Enrollment StartMar 1, 2007

Primary CompletionDec 1, 2007

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 19.5 years ago

Interventions

ceftarolinedrug

600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

vancomycin plus 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.

Placebodrug

Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.