Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
2-21 years
Phase:
PHASE4
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 oxacilli...
Detailed Description
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 oxacilli...
Eligibility Criteria
Inclusion
- Cystic Fibrosis diagnosis on accepted Cystic Fibrosis Foundation guidelines
- Inpatient
- Decision by treating physician to use intravenous ceftaroline
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03771313
Start Date
September 1 2017
End Date
July 31 2025
Last Update
September 5 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 42229