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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01026636
First received: December 3, 2009
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Staphylococcal Skin Infections
Streptococcal Infections
Drug: Ceftobiprole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

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 [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No Secondary Outcomes [ Time Frame: 16d ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftobiprole
Ceftobiprole 7mg/kg - 15mg/kg per day as 2h infusion
Drug: Ceftobiprole
Other Name: Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026636

Sponsors and Collaborators
Basilea Pharmaceutica
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT01026636     History of Changes
Other Study ID Numbers: CR012304, CSI-1001
Study First Received: December 3, 2009
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:
Staphylococcal Skin Infections
Skin Infections
Streptococcal Infections

Additional relevant MeSH terms:
Skin Diseases, Infectious
Staphylococcal Skin Infections
Streptococcal Infections
Infection
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014