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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Ceftaroline fosamil; Cephalosporins

Criteria

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