Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
1 other identifier
interventional
53
1 country
15
Brief Summary
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
15 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
First Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMay 14, 2014
May 1, 2014
1.8 years
February 15, 2011
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline.
This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported.
Up to 5 days
Study Arms (1)
Study of Blood Levels of Ceftaroline Fosamil
OTHERStudy of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
Interventions
Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion
Eligibility Criteria
You may qualify if:
- Male or female children with ages from birth to younger than 12 years
- Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection
- Sufficient intravascular access
- Negative urine pregnancy test
- Written informed consent from parent(s)and verbal informed assent from subject
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
- Moderate or severe renal impairment
- If female, currently pregnant or nursing
- Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level \> 3 times upper limit of normal
- Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study
- Use of probenecid within 3 days prior to dosing
- Receipt of a blood transfusion during the 24-hour period before enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Investigational Site
Phoenix, Arizona, 85008, United States
Investigational Site
Little Rock, Arkansas, 72202, United States
Investigational Site
Orange, California, 92868, United States
Investigational Site
San Diego, California, 92123, United States
Investigational Site
Indianapolis, Indiana, 46202, United States
Investigational Site
Louisville, Kentucky, 40202, United States
Investigational Site
Shreveport, Louisiana, 71113, United States
Investigational Site
Jackson, Mississippi, 39216, United States
Investigational Site
Omaha, Nebraska, 68198, United States
Investigational Site
Akron, Ohio, 44308, United States
Investigational Site
Cleveland, Ohio, 44106, United States
Investigational Site
Cleveland, Ohio, 44109, United States
Investigational site
Toledo, Ohio, 43606, United States
Investigational Site
Forth Worth, Texas, 76102, United States
Investigational Site
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 18, 2011
Study Start
April 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 14, 2014
Record last verified: 2014-05