Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A

ceftaroline

Group Type EXPERIMENTAL

ceftaroline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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ceftaroline for injection ceftaroline fosamil

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No