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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Infections

Treatments: Drug: Ceftaroline fosamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298843

P903-21

Details and patient eligibility

About

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

Full description

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Enrollment: 53 patients

Sex: All

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

53 participants in 1 patient group

Study of Blood Levels of Ceftaroline Fosamil

Other group

Description:

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

Treatment:

Drug: Ceftaroline fosamil