Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)

Inclusion Criteria:

• Male or female, 2 months to < 18 years old.
• Presence of CABP requiring hospitalization and IV antibacterial therapy

Exclusion Criteria:

• Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
• Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
• Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
• Non-infectious causes of pulmonary infiltrates.