A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age

Overview

This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children.

Full Title of Study: “An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients =3 Months to 17<18 Years of Age, Undergoing Treatment With Systemic Antibiotics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2010

Detailed Description

This purpose of this study will be to assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children. This study is an open-label (all patients will know the identity of the drug) single-dose, pharmacokinetic study in infants and children =3 months to <18 years of age who are medically stable as judged by the clinical investigator and require therapy with antibiotics. Patients will be given a 2-hour i.v. infusion (given directly into the vein) of 7, 10, or 15 mg/kg ceftobiprole. The study population will be grouped according to the following 4 age groups: =12 to <18 years of age; =6 to <12 years of age; =2 to <6 years of age; and =3 months to <2 years of age. Every attempt will be made to include patients of both sexes in each age group. Safety evaluations will include clinical laboratory tests (hematology, serum chemistry, and urinalysis), pregnancy testing, vital signs, physical examination, monitoring of adverse events, and recording of concomitant medications. Patients will be given a single 2-hour i.v. (given directly into the vein) infusion of ceftobiprole. The total duration of the study is approximately 18 days, including screening and posttreatment.

Interventions

  • Drug: Ceftobiprole

Arms, Groups and Cohorts

  • Experimental: Ceftobiprole
    • Ceftobiprole 7mg/kg – 15mg/kg per day as 2h infusion

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the pharmacokinetics of ceftobiprole when administered as a single dose of 7, 10, or 15 mg/kg in pediatric patients =3 months to <18 years of age who require therapeutic or prophylactic therapy with systemic antibiotics
    • Time Frame: The total duration of the study is approximately 18 days, including screening and posttreatment with prescreening, Day 1 and Day 2 post treatment

Secondary Measures

  • No Secondary Outcomes
    • Time Frame: 16d

Participating in This Clinical Trial

Inclusion Criteria

  • Infants (=3 months to <2 years of age) must have been born at =36 weeks of gestation
  • Documented or presumed, or be at risk for, bacterial infection(s) and receiving systemic antibiotic therapy
  • Stable medical condition

Exclusion Criteria

  • History of drug allergy or hypersensitivity to ß-lactam antibiotics such as penicillins, cephalosporins, or carbapenems
  • History of clinically significant cardiac arrhythmia, cystic fibrosis, chronic lung disease associated with abnormal pulmonary function, acute or chronic arthritis
  • History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Basilea Pharmaceutica
  • Collaborator
    • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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