Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633126
• Other study ID #: P903-15
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2008
• Last updated: February 11, 2013
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2013
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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 ß-lactam antimicrobial

• Past or current history of epilepsy or seizure disorder

• Critically ill or unstable patients

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Investigational site	Akron	Ohio
United States	Invetigational Site	Cleveland	Ohio
United States	Investigational Site	Durham	North Carolina
United States	Investigational Site	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 hours after infusion	No
Secondary	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.	Signing of ICF to last FU visit, study day 7 (+-2 days).	Yes