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Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
This is an open-label, single center, prospective study of patients with a diagnosis of cystic fibrosis (CF) and a history of methicillin-resistant Staphylococcus aureus (MRSA), also known as oxacillin-resistant Staphylococcus aureus (ORSA), being treated with intravenous ceftaroline. Patients will have intravenous ceftaroline dosed according to current recommendations based upon its approved usage in pediatric patients for community acquired pneumonia. The investigators will analyze pharmacokinetic (PK) and pharmacodynamic (PD) data using serum concentrations of ceftaroline measured at various time-points following infusion of ceftaroline to develop PK/PD guided dosing strategies of ceftaroline in pediatric CF patients that would be tailored to account for bacterial susceptibility and disease progression.
Key Details
Gender
All
Age Range
2 Years - 21 Years
Study Type
OBSERVATIONAL
Enrollment
8
Start Date
2017-09-01
Completion Date
2025-07-31
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
Ceftaroline
Patients will have intravenous ceftaroline dosed according to current recommendations based upon its approved usage in pediatric patients for community acquired pneumonia. Blood samples will be collected for PK/PD analysis.
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States