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

Completed · Phase 4

Conditions studied: Infections

In brief

The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.

Key facts

Study ID

NCT01298843

Run by

Forest Laboratories

People needed

53

Starts

2011-04-01

Expected to finish

2013-02-01

Last updated by the study team

2014-05-14

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Little Rock, Arkansas, United States
• Investigational Site — Orange, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — Indianapolis, Indiana, United States
• Investigational Site — Louisville, Kentucky, United States
• Investigational Site — Shreveport, Louisiana, United States
• Investigational Site — Jackson, Mississippi, United States
• Investigational Site — Omaha, Nebraska, United States
• Investigational Site — Akron, Ohio, United States
• Investigational Site — Cleveland, Ohio, United States
• Investigational Site — Cleveland, Ohio, United States
• Investigational site — Toledo, Ohio, United States
• Investigational Site — Forth Worth, Texas, United States
• Investigational Site — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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