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Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

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ClinicalTrials.gov Identifier: NCT00633126
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : February 12, 2013
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Infection Drug: ceftaroline Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
ceftaroline
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.
Other Names:
  • ceftaroline for injection
  • ceftaroline fosamil




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633126


Locations
United States, Kentucky
Investigational Site
Louisville, Kentucky, United States, 40202
United States, North Carolina
Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Investigational site
Akron, Ohio, United States, 44308
Invetigational Site
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Medical Monitor Cerexa Forest Laboratories

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00633126     History of Changes
Other Study ID Numbers: P903-15
First Posted: March 11, 2008    Key Record Dates
Results First Posted: February 12, 2013
Last Update Posted: March 14, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
PK
Pharmacokinetics

Additional relevant MeSH terms:
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents