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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-02-28

Brief Summary

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

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Detailed Description

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To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Conditions

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Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Study of Blood Levels of Ceftaroline Fosamil

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

Group Type OTHER

Ceftaroline fosamil

Intervention Type DRUG

Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion

Interventions

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Ceftaroline fosamil

Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No