Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis

• Status: Active, not recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Ceftaroline fosamil; Cephalosporins

Criteria

Inclusion Criteria:

• Cystic Fibrosis diagnosis on accepted Cystic Fibrosis Foundation guidelines

• Inpatient

• Decision by treating physician to use intravenous ceftaroline

Exclusion Criteria:

• less than 2 years old

• 22 years of age or older

• less than 15 kg weight

• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 fold upper limit of normal

• Gamma-glutamyltransferase (GGT) > 3 fold above upper limit of normal

• Total bilirubin > 2 mg/dL

• Platelets < 50,000

• Patients without documented CF

• Non-English speaking patients/families