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

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)

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

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Inclusion Criteria:

• Presence of CABP warranting 3 days of initial hospitalization
• Confirmed presence of indicators of complicated CABP

Exclusion Criteria:

• Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
• Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
• Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
• Non-infectious causes of pulmonary infiltrates