A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
Primary Purpose
Staphylococcal Skin Infections, Streptococcal Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ceftobiprole
Sponsored by
About this trial
This is an interventional basic science trial for Staphylococcal Skin Infections focused on measuring Staphylococcal Skin Infections, Skin Infections, Streptococcal Infections
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ceftobiprole
Arm Description
Ceftobiprole 7mg/kg - 15mg/kg per day as 2h infusion
Outcomes
Primary Outcome 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
Secondary Outcome Measures
No Secondary Outcomes
Full Information
NCT ID
NCT01026636
First Posted
December 3, 2009
Last Updated
July 26, 2012
Sponsor
Basilea Pharmaceutica
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01026636
Brief Title
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
Official Title
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
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infections, Streptococcal Infections
Keywords
Staphylococcal Skin Infections, Skin Infections, Streptococcal Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceftobiprole
Arm Type
Experimental
Arm Description
Ceftobiprole 7mg/kg - 15mg/kg per day as 2h infusion
Intervention Type
Drug
Intervention Name(s)
Ceftobiprole
Other Intervention Name(s)
Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
No Secondary Outcomes
Time Frame
16d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
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