Infections
Conditions
Keywords
Confirmed or Suspected Infections
Brief summary
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
Detailed description
To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.
Interventions
Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion
Sponsors
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Up to 5 days | 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. |
Countries
United States
Outcome results
None listed