Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

February 2, 2017 updated by: Forest Laboratories

Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy

The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44308
        • Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Invetigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
  • Body mass index (weight [kg]/height squared [m2]) of no more than 30
  • Males and females between 12 and 17 years of age, inclusive

Exclusion Criteria:

  • History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
  • Past or current history of epilepsy or seizure disorder
  • Critically ill or unstable patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
ceftaroline
Drug: ceftaroline
Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
Other Names:
  • ceftaroline for injection
  • ceftaroline fosamil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.
Time Frame: 12 hours after infusion
The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.
12 hours after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).
Time Frame: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).

A TEAE is any untoward medical occurrence a subject experiences following study drug administration.

Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7.
Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Medical Monitor Cerexa, Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P903-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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