Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Forest Laboratories

Status and phase: Completed; Phase 1

Conditions: Infection

Treatments: Drug: ceftaroline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633126

P903-15

Details and patient eligibility

About

The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

Full description

The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Enrollment: 9 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
• Body mass index (weight [kg]/height squared [m2]) of no more than 30
• Males and females between 12 and 17 years of age, inclusive

Exclusion criteria

• History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
• Past or current history of epilepsy or seizure disorder
• Critically ill or unstable patients

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

A

Experimental group

Description:

ceftaroline

Treatment:

Drug: ceftaroline