The use of extrapolation based on modeling and simulation to support high-dose regimens of ceftaroline fosamil in pediatric patients with complicated skin and soft-tissue infections.
Adolescent
Adult
Anti-Bacterial Agents
/ administration & dosage
Cephalosporins
/ administration & dosage
Child
Child, Preschool
Clinical Trials as Topic
Computer Simulation
Female
Humans
Infant
Infant, Newborn
Male
Microbial Sensitivity Tests
Models, Biological
Renal Insufficiency
/ blood
Skin Diseases, Infectious
/ blood
Soft Tissue Infections
/ blood
Staphylococcal Infections
/ blood
Staphylococcus aureus
Ceftaroline
Journal
CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
revised:
29
01
2021
received:
02
12
2021
accepted:
31
01
2021
pubmed:
10
3
2021
medline:
22
1
2022
entrez:
9
3
2021
Statut:
ppublish
Résumé
A model-informed drug development approach was used to select ceftaroline fosamil high-dose regimens for pediatric patients with complicated skin and soft-tissue infections caused by Staphylococcus aureus with a ceftaroline minimum inhibitory concentration (MIC) of 2 or 4 mg/L. Steady-state ceftaroline concentrations were simulated using a population pharmacokinetics (PK) model for ceftaroline fosamil and ceftaroline including data from 304 pediatric subjects and 944 adults. Probability of target attainment (PTA) for various simulated pediatric high-dose regimens and renal function categories were calculated based on patients achieving 35% fT>MIC (S. aureus PK/pharmacodynamic target for 2-log
Identifiants
pubmed: 33687148
doi: 10.1002/psp4.12608
pmc: PMC8213416
doi:
Substances chimiques
Anti-Bacterial Agents
0
Cephalosporins
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
551-563Informations de copyright
© 2021 Pfizer R&D UK Limited. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
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