Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy
1 other identifier
interventional
9
1 country
4
Brief Summary
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
March 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
February 12, 2013
CompletedMarch 14, 2017
February 1, 2017
11 months
March 3, 2008
March 28, 2012
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.
12 hours after infusion
Secondary Outcomes (1)
Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).
Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).
Study Arms (1)
A
EXPERIMENTALceftaroline
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Investigational Site
Louisville, Kentucky, 40202, United States
Investigational Site
Durham, North Carolina, 27710, United States
Investigational site
Akron, Ohio, 44308, United States
Invetigational Site
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Friedland, MD
- Organization
- Cerexa, Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor Cerexa
Forest Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2008
First Posted
March 11, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
March 14, 2017
Results First Posted
February 12, 2013
Record last verified: 2017-02