Viewing Study NCT03439124



Ignite Creation Date: 2024-05-06 @ 11:07 AM
Last Modification Date: 2024-10-26 @ 12:40 PM
Study NCT ID: NCT03439124
Status: COMPLETED
Last Update Posted: 2023-05-12
First Post: 2018-01-30

Brief Title: Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
Sponsor: Basilea Pharmaceutica
Organization: Basilea Pharmaceutica

Study Overview

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
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None