Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

Community-acquired Pneumonia (CAP) Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Community-acquired Pneumonia (CAP)
• Healthcare-Associated Pneumonia
• Hospital-acquired Pneumonia (HAP)
• Pneumonia

• NCT number: NCT03439124
• Study type: Interventional
• Source: Basilea Pharmaceutica
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2017
• Completion date: March 16, 2020