This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: February 15, 2011
Last updated: May 13, 2014
Last verified: May 2014
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.

Condition Intervention Phase
Infections Drug: Ceftaroline fosamil Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 5 days ]
    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.

Enrollment: 53
Study Start Date: April 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study of Blood Levels of Ceftaroline Fosamil
Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
Drug: Ceftaroline fosamil
Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion

Detailed Description:
To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects must meet the following inclusion criteria:

  • 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

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

  • 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
  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 identifier: NCT01298843

United States, Arizona
Investigational Site
Phoenix, Arizona, United States, 85008
United States, Arkansas
Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
Investigational Site
Orange, California, United States, 92868
Investigational Site
San Diego, California, United States, 92123
United States, Indiana
Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
Investigational Site
Shreveport, Louisiana, United States, 71113
United States, Mississippi
Investigational Site
Jackson, Mississippi, United States, 39216
United States, Nebraska
Investigational Site
Omaha, Nebraska, United States, 68198
United States, Ohio
Investigational Site
Akron, Ohio, United States, 44308
Investigational Site
Cleveland, Ohio, United States, 44106
Investigational Site
Cleveland, Ohio, United States, 44109
Investigational site
Toledo, Ohio, United States, 43606
United States, Texas
Investigational Site
Forth Worth, Texas, United States, 76102
United States, West Virginia
Investigational Site
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Forest Laboratories
  More Information

Responsible Party: Forest Laboratories Identifier: NCT01298843     History of Changes
Other Study ID Numbers: P903-21
Study First Received: February 15, 2011
Last Updated: May 13, 2014

Keywords provided by Forest Laboratories:
Confirmed or Suspected Infections

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 22, 2017