Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Phase 1

Completed

• Conditions: Infection
• Interventions: Drug: ceftaroline

• Registration Number: NCT00633126
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-11
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-03-28
• Results First Submitted QC: 2013-02-11
• Results First Posted: 2013-02-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	ceftaroline	ceftaroline

Primary Outcome Measures

Name	Time	Method
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.	12 hours after infusion	The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Investigational Site; 🇺🇸 Durham, North Carolina, United States

Investigational site; 🇺🇸 Akron, Ohio, United States

Invetigational Site; 🇺🇸 Cleveland, Ohio, United States