Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
|ClinicalTrials.gov Identifier: NCT00633126|
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : February 12, 2013
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: ceftaroline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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 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 ]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 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|