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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01298843
First received: February 15, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298843

Locations
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, 44109
Investigational Site
Cleveland, Ohio, United States, 44106
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
Cerexa, Inc.
Forest Laboratories
  More Information

No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01298843     History of Changes
Other Study ID Numbers: P903-21
Study First Received: February 15, 2011
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerexa, Inc.:
Confirmed or Suspected Infections

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013