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Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 11, 2008
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

Condition Intervention Phase
Infection Drug: ceftaroline Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 9
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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

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

Information from the National Library of Medicine

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

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
  Contacts and Locations
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

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
Study Director: Medical Monitor Cerexa Forest Laboratories
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00633126     History of Changes
Other Study ID Numbers: P903-15
First Submitted: March 3, 2008
First Posted: March 11, 2008
Results First Submitted: March 28, 2012
Results First Posted: February 12, 2013
Last Update Posted: March 14, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:

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