Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy|
- 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 ] [ Designated as safety issue: No ]The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.
- 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 ICF to last FU visit, study day 7 (+-2 days). ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||March 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
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.
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Akron, Ohio, United States, 44308|
|Cleveland, Ohio, United States, 44106|
|Study Director:||Medical Monitor Cerexa||Cerexa, Inc.|