Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Phase 1CompletedNCT00633126

Forest Laboratories9 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Infection

Interventions

ceftarolineDRUG

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (4)

Investigational Site

Louisville, Kentucky, United States

Investigational Site

Durham, North Carolina, United States

Investigational site

Akron, Ohio, United States

Invetigational Site

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.

Time frame: 12 hours after infusion

Secondary Outcomes

Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).

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.

Time frame: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).

Data from ClinicalTrials.gov

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