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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
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

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

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 3, 2009
    Last Updated
    July 26, 2012
    Sponsor
    Basilea Pharmaceutica
    Collaborators
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    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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