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COMPLETEDPhase 4NCT01298843

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

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

Lead sponsor: Forest Laboratories•15 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Forest Laboratories

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Age

0 - 11 years

Sex

ALL

Healthy Volunteers

No

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

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 14, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment53

Start dateApr 2011

Last updatedMay 14, 2014

Condition

Locations shown

Investigational Site

Phoenix, Arizona

Investigational Site

Little Rock, Arkansas

Investigational Site

Orange, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2014Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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