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

NCT01298843·15 sites·ClinicalTrials.gov

What this study is about

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Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Forest Laboratories

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Age

0–11

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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

The record

StatusCompleted

PhasePhase 4

Taking part53

StartedApr 2011

UpdatedMay 14, 2014

Conditions

Where15

Investigational Site
Phoenix, Arizona, United States
Investigational Site
Little Rock, Arkansas, United States
Investigational Site
Orange, California, United States