Clinical trial NCT01298843: Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections
Keywords: Confirmed or Suspected Infections
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 53
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

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

Eligibility 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

Primary outcomes:
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.
timeFrame: Up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Orange
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Investigational Site
state: Louisiana
city: Jackson
country: United States
facility: Investigational Site
state: Mississippi
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: Akron
country: United States
facility: Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Investigational site
state: Ohio
city: Forth Worth
country: United States
facility: Investigational Site
state: Texas
city: Morgantown
country: United States
facility: Investigational Site
state: West Virginia
Study officials:
References: