Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Pediatric Patients Aged From 3 Months to Less Than 18 Years With Hospital-acquired Pneumonia or Community-acquired Pneumonia Requiring Hospitalisation

This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.

This was a randomized, investigator-blind, active-controlled multi-center study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared with IV standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients aged 3 months to less than 18 years with HAP or CAP requiring hospitalization and therapy with IV antibiotics. Randomization was stratified by four age groups (3 months to < 2 years; 2 years to < 6 years; 6 years to < 12 years; 12 years to < 18 years), and by diagnosis of HAP or CAP.

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