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

Phase 4

Completed

• Conditions: Infections
• Interventions: Drug: Ceftaroline fosamil

• Registration Number: NCT01298843
• Lead Sponsor: Forest Laboratories

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.

Study Timeline

• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Start: 2011-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study of Blood Levels of Ceftaroline Fosamil	Ceftaroline fosamil	Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Investigational site; 🇺🇸 Toledo, Ohio, United States

Investigational Site; 🇺🇸 Morgantown, West Virginia, United States