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Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia.
Paediatr Drugs. 2021 Nov; 23(6):549-563.PD

Abstract

Community-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vitro activity against Gram-positive pathogens (including MRSA and multidrug-resistant Streptococcus pneumoniae) and common Gram-negative organisms, is approved in the European Union and the United States for children with CAP/CABP or cSSTI/ABSSSI. Ceftaroline fosamil has completed a pediatric investigation plan including safety, efficacy, and pharmacokinetic evaluations in patients with ages ranging from birth to 17 years. It has demonstrated similar clinical and microbiological efficacy to best available existing treatments in phase III-IV trials in patients aged ≥ 2 months to < 18 years with CABP or ABSSSI, with a safety profile consistent with the cephalosporin class. It is also approved in the European Union for neonates with CAP or cSSTI, and in the US for neonates with ABSSSI. Ceftaroline fosamil dosing for children (including renal function adjustments) is supported by pharmacokinetic/pharmacodynamic modeling and simulations in appropriate age groups, and includes the option of 5- to 60-min intravenous infusions for standard doses, and a high dose for cSSTI patients with MRSA isolates, with a ceftaroline minimum inhibitory concentration of 2-4 mg/L. Considered together, these data suggest ceftaroline fosamil may be beneficial in the management of CAP/CABP and cSSTI/ABSSSI in children.

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Authors+Show Affiliations

Esposito S
Pediatric Clinic, Pietro Barilla Children's Hospital, University of Parma, Building 15, Via Gramsci 14, 43126, Parma, Italy. susannamariaroberta.esposito@unipr.it.
Carrothers TJ
AbbVie, Madison, NJ, USA.
Riccobene T
AbbVie, Madison, NJ, USA.
Stone GG
Pfizer, Groton, CT, USA.
Kantecki M
Pfizer, Paris, France.

MeSH

CephalosporinsChildHumansInfant, NewbornMethicillin-Resistant Staphylococcus aureusPneumoniaSoft Tissue Infections

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

34462863

Citation

Esposito, Susanna, et al. "Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia." Paediatric Drugs, vol. 23, no. 6, 2021, pp. 549-563.
Esposito S, Carrothers TJ, Riccobene T, et al. Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia. Paediatr Drugs. 2021;23(6):549-563.
Esposito, S., Carrothers, T. J., Riccobene, T., Stone, G. G., & Kantecki, M. (2021). Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia. Paediatric Drugs, 23(6), 549-563. https://doi.org/10.1007/s40272-021-00468-w
Esposito S, et al. Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia. Paediatr Drugs. 2021;23(6):549-563. PubMed PMID: 34462863.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia. AU - Esposito,Susanna, AU - Carrothers,Timothy J, AU - Riccobene,Todd, AU - Stone,Gregory G, AU - Kantecki,Michal, Y1 - 2021/08/31/ PY - 2021/08/16/accepted PY - 2021/9/1/pubmed PY - 2021/11/26/medline PY - 2021/8/31/entrez SP - 549 EP - 563 JF - Paediatric drugs JO - Paediatr Drugs VL - 23 IS - 6 N2 - Community-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vitro activity against Gram-positive pathogens (including MRSA and multidrug-resistant Streptococcus pneumoniae) and common Gram-negative organisms, is approved in the European Union and the United States for children with CAP/CABP or cSSTI/ABSSSI. Ceftaroline fosamil has completed a pediatric investigation plan including safety, efficacy, and pharmacokinetic evaluations in patients with ages ranging from birth to 17 years. It has demonstrated similar clinical and microbiological efficacy to best available existing treatments in phase III-IV trials in patients aged ≥ 2 months to < 18 years with CABP or ABSSSI, with a safety profile consistent with the cephalosporin class. It is also approved in the European Union for neonates with CAP or cSSTI, and in the US for neonates with ABSSSI. Ceftaroline fosamil dosing for children (including renal function adjustments) is supported by pharmacokinetic/pharmacodynamic modeling and simulations in appropriate age groups, and includes the option of 5- to 60-min intravenous infusions for standard doses, and a high dose for cSSTI patients with MRSA isolates, with a ceftaroline minimum inhibitory concentration of 2-4 mg/L. Considered together, these data suggest ceftaroline fosamil may be beneficial in the management of CAP/CABP and cSSTI/ABSSSI in children. SN - 1179-2019 UR - https://www.unboundmedicine.com/medline/citation/34462863/Ceftaroline_Fosamil_for_Treatment_of_Pediatric_Complicated_Skin_and_Soft_Tissue_Infections_and_Community_Acquired_Pneumonia_ DB - PRIME DP - Unbound Medicine ER -