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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01298843
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : May 14, 2014
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.

Condition or disease Intervention/treatment Phase
Infections Drug: Ceftaroline fosamil Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
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
Study Start Date : April 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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. [ 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01298843

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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
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Responsible Party: Forest Laboratories Identifier: NCT01298843    
Other Study ID Numbers: P903-21
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Keywords provided by Forest Laboratories:
Confirmed or Suspected Infections
Additional relevant MeSH terms:
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Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents