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

Infections Clinical Trial

Official title:

Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298843
• Other study ID #: P903-21
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2011
• Last updated: May 13, 2014
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 11 Years

Eligibility

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 ß-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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infection
• Infections

Intervention

Drug:
• Ceftaroline fosamil
Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion

Locations

Country	Name	City	State
United States	Investigational Site	Akron	Ohio
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Forth Worth	Texas
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Jackson	Mississippi
United States	Investigational Site	Little Rock	Arkansas
United States	Investigational Site	Louisville	Kentucky
United States	Investigational Site	Morgantown	West Virginia
United States	Investigational Site	Omaha	Nebraska
United States	Investigational Site	Orange	California
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	San Diego	California
United States	Investigational Site	Shreveport	Louisiana
United States	Investigational site	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes