Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

• Status: Completed
• Trial end date: 2020-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Treatments: Ceftazidime; Ceftobiprole; Ceftobiprole medocaril; Ceftriaxone; Cephalosporins

Criteria

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