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 pneumoniarequiring 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-carecephalosporin 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, orneed for antibiotic coverage with a macrolide
• Pertussis, chemical pneumonitis, or cystic fibrosis
• Severe immunodeficiency
• Significant laboratory abnormalities including: Hematocrit <20%; absolute neutrophilcount <0.5x10⁹/L; platelet count <50x10⁹/L; alanine aminotransferase, aspartateaminotransferase, 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 beforerandomization
• History of a previous clinically-relevant hypersensitivity or serious adverse reactionto beta lactam antibiotics or to vancomycin
• Poorly controlled seizure disorder
• Other exclusion criteria may apply