American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2025
Ceftobiprole: A therapeutic update.
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Hitt Emily M, Bowers Dana R
Аннотация
PURPOSE: The purpose of this therapy update is to highlight new clinical studies comparing ceftobiprole to current therapies and provide evidence for its suggested role in therapeutic management of selected infectious diseases.
SUMMARY: Antimicrobial resistance continues to be a global health problem, and newer targeted antimicrobials are necessary to combat increasing rates of problematic infections. More specifically, targeted antimicrobials against methicillin-resistant Staphylococcus aureus are needed. Ceftobiprole has been marketed internationally for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and hospital-acquired pneumonia. While Food and Drug Administration approval was previously pursued for its use in acute bacterial skin and skin structure infections in the US, the Food and Drug Administration issued a complete response letter determining that study data were unreliable and recommended completion of additional studies. In April 2024, ceftobiprole was granted approval for 3 indications in the US based on updated clinical study data. Ceftobiprole is the second fifth-generation cephalosporin to be developed and approved for clinical use.
CONCLUSION: Ceftobiprole has been shown to be safe and effective in treating specific infectious diseases such as bloodstream infections, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia. Its use should be considered when targeting infections caused by methicillin-resistant S. aureus where other therapeutic options may be limited. However, additional real-world data on the efficacy of ceftobiprole should be continually monitored as experience in the US increases.
SUMMARY: Antimicrobial resistance continues to be a global health problem, and newer targeted antimicrobials are necessary to combat increasing rates of problematic infections. More specifically, targeted antimicrobials against methicillin-resistant Staphylococcus aureus are needed. Ceftobiprole has been marketed internationally for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and hospital-acquired pneumonia. While Food and Drug Administration approval was previously pursued for its use in acute bacterial skin and skin structure infections in the US, the Food and Drug Administration issued a complete response letter determining that study data were unreliable and recommended completion of additional studies. In April 2024, ceftobiprole was granted approval for 3 indications in the US based on updated clinical study data. Ceftobiprole is the second fifth-generation cephalosporin to be developed and approved for clinical use.
CONCLUSION: Ceftobiprole has been shown to be safe and effective in treating specific infectious diseases such as bloodstream infections, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia. Its use should be considered when targeting infections caused by methicillin-resistant S. aureus where other therapeutic options may be limited. However, additional real-world data on the efficacy of ceftobiprole should be continually monitored as experience in the US increases.