Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age - Full Text View

Sponsored by:	Cerexa, Inc.
Information provided by:	Cerexa, Inc.
ClinicalTrials.gov Identifier:	NCT00633126

Purpose

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

Condition	Intervention	Phase
Infection	Drug: ceftaroline	Phase I

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

Evaluate the single-dose pharmacokinetic (PK) profile of ceftaroline administered by intravenous (IV) infusion in subjects 12 to 17 years of age [ Time Frame: various time points during and after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety [ Time Frame: AEs from the start of infusion until at least through the follow-up evaluation ] [ Designated as safety issue: Yes ]

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
A: Experimental 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.

Detailed Description:

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

Eligibility

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

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 ( Senior Vice President, Clinical Development )
Study ID Numbers:	P903-15
Study First Received:	March 3, 2008
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00633126 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cerexa, Inc.:

PK
Pharmacokinetics

Study placed in the following topic categories:

Anti-Bacterial Agents

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on September 10, 2009