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A phase 3, randomized, investigator-blinded trial comparing ceftobiprole with a standard-of-care cephalosporin, with or without vancomycin, for the treatment of pneumonia in pediatric patients

The Pediatric Infectious Disease Journal May 19, 2021

Bosheva M, Gujabidze R, Károly E, et al. - In this multicenter, investigator-blinded, active-controlled, phase 3 study, researchers sought to assess the safety and effectiveness of ceftobiprole vs standard-of-care (SoC) cephalosporin treatments, with or without vancomycin, in pediatric patients with hospital-acquired pneumonia (HAP) or community-acquired pneumonia (CAP) requiring hospitalization. For this analysis, patients 3 months to < 18 years old with HAP or CAP requiring hospitalization were randomized (2:1) to ceftobiprole vs standard-of-care (SoC) IV cephalosporin treatments (ceftazidime or ceftriaxone), with or without vancomycin. In total, 138 patients were randomly assigned to receive either ceftobiprole (n = 94) or a SoC cephalosporin (n = 44). Ceftobiprole was well tolerated and showed similar effectiveness to SoC cephalosporins in pediatric patients with HAP or CAP requiring hospitalization in this small phase 3 study.

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