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: May 13, 2014
Last verified: May 2014

February 15, 2011
May 13, 2014
April 2011
February 2013   (final data collection date for primary outcome measure)
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.
  • 2. To evaluate plasma concentrations - time profile of ceftaroline fosamil by patient, age cohort and dosage level. [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]
    Plasma concentration of ceftaroline fosamil and its metabolites from blood samples will be evaluated, PK profile will be characterized, and adverse events and safety laboratory parameters will be monitored and analyzed in safety population.
  • 1. To evaluate the single-dose pharmacokinetic profile of ceftaroline fosamil. [ Time Frame: Up to 5 days ] [ Designated as safety issue: Yes ]
    Plasma concentration of ceftaroline fosamil and its metabolites from blood samples will be evaluated, PK profile will be characterized, and adverse events and safety laboratory parameters will be monitored and analyzed in safety population.
  • 3. To evaluate safety and tolerability of ceftaroline fosamil following a single dose. [ Time Frame: Up to 5 days ] [ Designated as safety issue: Yes ]
    Plasma concentration of ceftaroline fosamil and its metabolites from blood samples will be evaluated, PK profile will be characterized, and adverse events and safety laboratory parameters will be monitored and analyzed in safety population.
Complete list of historical versions of study NCT01298843 on ClinicalTrials.gov Archive Site
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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

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

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Interventional
Phase 4
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Infections
Drug: Ceftaroline fosamil
Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion
Study of Blood Levels of Ceftaroline Fosamil
Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
Intervention: Drug: Ceftaroline fosamil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
up to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01298843
P903-21
Yes
Cerexa, Inc.
Cerexa, Inc.
Forest Laboratories
Not Provided
Cerexa, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP