Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

Inclusion Criteria: * Male of female aged 3 months to \< 18 years with a body weight of at least 5 kg * Diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalization and administration of IV antibiotic therapy * New or progressive imaging findings consistent with bacterial pneumonia * Requirement for IV antibacterial treatment for pneumonia * Other inclusion criteria may apply Exclusion Criteria: * Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care cephalosporin treatment (± vancomycin) * On mechanical ventilation * Chest trauma with severe lung contusion or flail chest * Acute respiratory distress syndrome * Empyema or lung abscess * Anatomical bronchial obstruction * Active or currently treated pulmonary tuberculosis * Atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide * Pertussis, chemical pneumonitis, or cystic fibrosis * Severe immunodeficiency * Significant laboratory abnormalities including: Hematocrit \<20%; absolute neutrophil count \<0.5x10⁹/L; platelet count \<50x10⁹/L; alanine aminotransferase, aspartate aminotransferase, or bilirubin \>5 times the age-specific upper limit of normal; * Creatinine clearance \<50 mL/min/1.73 m² * Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization * History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin * Poorly controlled seizure disorder * Other exclusion criteria may apply