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

NCT03771313 | Completed Phase 4 FDA Drug

• 1 other identifier: Ceftaroline CF PK/PD_2017-2276
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Ceftaroline Exposure and PK/PD Target Attainment

  Interpret PK/PD target attainment based on percent time of the free ceftaroline concentration (=PK) above minimum inhibitory concentration (=PD index)

  12-hour maximum, single visit

Secondary Outcomes (4)

• FEV1 Percentage Change Assessment

  12-hour maximum, single visit

• Treatment Failures

  12-hour maximum, single visit

• Side Effects

  12-hour maximum, single visit

• Pulmonary Exacerbations

  12-hour maximum, single visit

Study Arms (1)

PK/PD

OTHER

Open-label prospective study with participants receiving treating physician-approved intravenous ceftaroline, dosed according to current recommendations. Blood samples collected at baseline, 1 hour, 1.5 hours, 3 hours, and 6 hours after infusion.

Drug: Ceftaroline

Interventions

Ceftaroline DRUG

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.

Also known as: Ceftaroline fosamil,Teflaro, Zinforo

PK/PD

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cystic Fibrosis diagnosis on accepted Cystic Fibrosis Foundation guidelines
• Inpatient
• Decision by treating physician to use intravenous ceftaroline

You may not qualify if:

• less than 2 years old
• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 42229, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Ceftaroline

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alexander Vinks, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single center, prospective study

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: December 11, 2018
• Study Start: September 1, 2017
• Primary Completion: November 30, 2024
• Study Completion: July 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2024-11

Locations

US (1)