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

Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection

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

Study Overview

• Status: Completed
• Conditions: Infections
• Intervention / Treatment: Drug: Ceftaroline fosamil

Detailed Description

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Investigational Site
  • California
    • Orange, California, United States, 92868
      • Investigational Site
    • San Diego, California, United States, 92123
      • Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71113
      • Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44308
      • Investigational Site
    • Cleveland, Ohio, United States, 44106
      • Investigational Site
    • Cleveland, Ohio, United States, 44109
      • Investigational Site
    • Toledo, Ohio, United States, 43606
      • Investigational Site
  • Texas
    • Forth Worth, Texas, United States, 76102
      • Investigational Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study of Blood Levels of Ceftaroline Fosamil; Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital	Drug: Ceftaroline fosamil; Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 5 days

Collaborators and Investigators

• Sponsor: Forest Laboratories

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Confirmed or Suspected Infections
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Anti-Bacterial Agents; Ceftaroline fosamil
• Other Study ID Numbers: P903-21