Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

Study Overview
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Brief Summary
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The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.

Detailed Description
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To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Official Title
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Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection

Conditions
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Infections

Intervention / Treatment
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* Drug: Ceftaroline fosamil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet the following inclusion criteria: Male or female children with ages from birth to younger than 12 years Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection Sufficient intravascular access Negative urine pregnancy test Written informed consent from parent(s)and verbal informed assent from subject Exclusion Criteria: Subjects must NOT meet any of the following exclusion criteria: History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial Past or current history of epilepsy or seizure disorder Moderate or severe renal impairment If female, currently pregnant or nursing Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level > 3 times upper limit of normal Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study Use of probenecid within 3 days prior to dosing Receipt of a blood transfusion during the 24-hour period before enrollment

Ages Eligible for Study
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Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study of Blood Levels of Ceftaroline Fosamil<br>Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital | Drug: Ceftaroline fosamil<br>* Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline. | This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported. | Up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Confirmed or Suspected Infections