CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
Ceftaroline fosamil +1 moredrug
Likely dose
Ceftaroline fosamil 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/NCT01645735
NCT01645735Phase 4Completed
CompareCT.gov

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus

Forest Laboratories·interventional·Posted Jul 20, 2012·Updated Feb 1, 2016

In Brief

A Phase 4 clinical trial evaluating Ceftaroline fosamil and Ceftriaxone plus vancomycin for Infections. Completed, enrolled 49 participants across 31 sites in 8 countries.

Detailed Summary

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections
CountriesGeorgia, Hungary, Poland, Romania, Russia, Spain, Ukraine, United States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2012
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.0 years ago

Interventions

Ceftaroline fosamildrug

Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days

Ceftriaxone plus vancomycindrug

Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days