Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633126
|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||Forest Laboratories|