NCT01645735

Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Infections

Interventions

Type	Name	Description
DRUG	Ceftaroline fosamil	Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
DRUG	Ceftriaxone plus vancomycin	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

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-07-20
• Last updated: 2016-02-01
• Results posted: 2016-02-01

Locations

31 sites across 8 countries: United States, Georgia, Hungary, Poland, Romania, Russia, Spain, Ukraine