Phase 1
Completed N=9
Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
Source: ClinicalTrials.gov NCT00633126 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Feb 2013
Primary outcomePrimary: The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. — 15276 ng/mL
Summary
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. |
15276 | — |
| SECONDARY Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated). |
8 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
- Body mass index (weight [kg]/height squared [m2]) of no more than 30
- Males and females between 12 and 17 years of age, inclusive
Exclusion Criteria
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- Past or current history of epilepsy or seizure disorder
- Critically ill or unstable patients
Data sourced from ClinicalTrials.gov (NCT00633126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.