NCT03771313Completed
Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 8 (actual)
- First submitted
- 11 Jul 2018
- Start date
- 1 Sept 2017
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Cystic fibrosis
- NCT number
- NCT03771313
What you commit to
- Study type: Observational
- Participants enrolled: 8
- From 1 Sept 2017 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 fold upper limit of normal
- Total bilirubin \> 2 mg/dL
- Platelets \< 50,000
Age
- less than 2 years old
- 22 years of age or older
Other
- less than 15 kg weight
- Gamma-glutamyltransferase (GGT) \> 3 fold above upper limit of normal
- Patients without documented CF
- Non-English speaking patients/families
Who the study is looking for
- Cystic Fibrosis diagnosis on accepted Cystic Fibrosis Foundation guidelines
- Inpatient
- Decision by treating physician to use intravenous ceftaroline
Age in the registry: 2 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.