Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00633126
First received: March 3, 2008
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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: 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

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

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 ] [ Designated as safety issue: No ]
    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 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.



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
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Cerexa, Inc.
Investigators
Study Director: Medical Monitor Cerexa Cerexa, Inc.
  More Information

No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT00633126     History of Changes
Other Study ID Numbers: P903-15
Study First Received: March 3, 2008
Results First Received: March 28, 2012
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerexa, Inc.:
PK
Pharmacokinetics

ClinicalTrials.gov processed this record on August 21, 2014