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

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

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.

Study Overview

• Status: Completed
• Conditions: Streptococcal Infections; Staphylococcal Skin Infections
• Intervention / Treatment: Drug: Ceftobiprole

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ceftobiprole; Ceftobiprole 7mg/kg - 15mg/kg per day as 2h infusion	Drug: Ceftobiprole; Other Names: Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	The total duration of the study is approximately 18 days, including screening and posttreatment with prescreening, Day 1 and Day 2 post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
No Secondary Outcomes	16d

Collaborators and Investigators

• Sponsor: Basilea Pharmaceutica
• Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 26, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Staphylococcal Skin Infections; Skin Infections; Streptococcal Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Disease Attributes; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Suppuration; Skin Diseases, Bacterial; Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Streptococcal Infections; Anti-Infective Agents; Anti-Bacterial Agents; Ceftobiprole; Ceftobiprole medocaril; Cephalosporins
• Other Study ID Numbers: CR012304; CSI-1001 (Other Identifier: Basilea)