Ceftobiprole medocaril (BAL-5788) for the treatment of complicated skin infections

Abstract

With resistance of S. aureus, the most prevalent identified pathogen in skin and soft tissue infections, on the rise, the need for safe, effective, and well-tolerated antibiotics is crucial. Ceftobiprole medocaril (BAL-5788), ceftobiprole's parenteral prodrug, is a bactericidal cephalosporin with broad Gram-positive and Gram-negative activity that has shown to be well-tolerated and noninferior to vancomycin and vancomycin plus ceftazidime in the treatment of MRSA complicated skin and skin structure infections (cSSSIs) in clinical trials. Areas Covered: This article overviews ceftobiprole medocaril's use for cSSSI, with specific focus on clinical efficacy and safety data in addition to summary information on its basic chemistry, microbiological profile, and pharmacokinetic/pharmacodynamic relationships supporting its use in cSSSIs. Information sources include peer-reviewed scientific literature, conference proceedings, publically available regulatory reports, as well as information from the drug sponsor's website. Expert Commentary: With increasing antibiotic resistance, safe, effective antibiotics agents are a welcome sight. There has been clinical evidence in support of using ceftobiprole for treatment of Gram-positive and -negative infections, including MRSA and susceptible P. aeruginosa. This broad antimicrobial activity might allow ceftobiprole to be an alternative to dual therapy combinations when potential drug toxicities, drug-drug or drug-disease interactions are concerns for other agents.

Ceftobiprole medocaril (Zevtera) – FDA approved antibiotic for three infections including methicillin-resistant Staphylococcus aureus

“…In a pivotal clinical trial assessing the efficacy of Zevtera in treating Staphylococcus aureus bloodstream infections 16,17 including right-sided infective endocarditis, the study demonstrated significant therapeutic benefits. The trial was a randomized, double-blind, multicenter study comparing ceftobiprole to standard therapy, typically involving vancomycin with or without an aminoglycoside.…”

New drugs for methicillin-resistant Staphylococcus aureus skin and soft tissue infections

“…Ceftobiprole has broad-spectrum activity against Gram-positive pathogens, including resistant strains of streptococci and MRSA, and Gram-negative organisms, including Enterobacterales and ceftazidime-susceptible P. aeruginosa [46]. Ceftobiprole has the capacity to bind to penicillin binding protein (PBP) 2a and PBP2x, conferring activity against MRSA.…”

The role of methicillin-resistant Staphylococcus aureus in skin and soft tissue infections

“…However, ceftobiprole is currently approved in Canada and in 13 countries in Europe for treatment of adults with community-acquired and hospital-acquired pneumonia, with the exception of ventilator-associated pneumonia. Despite data coming from phase III trials supporting the use of ceftobiprole for the treatment of cSSTIs, the drug failed to gain approval for this indication from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) so far [48].…”