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

NCT01026636 | Completed Phase 1

• 2 other identifiers: CR012304CSI-1001
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Staphylococcal Skin Infections; Streptococcal Infections

Keywords

Staphylococcal Skin Infections; Skin Infections; Streptococcal Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• No Secondary Outcomes

  16d

Study Arms (1)

Ceftobiprole

EXPERIMENTAL

Ceftobiprole 7mg/kg - 15mg/kg per day as 2h infusion

Drug: Ceftobiprole

Interventions

Ceftobiprole DRUG

Also known as: Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion

Ceftobiprole

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

MeSH Terms

Conditions

Staphylococcal Skin Infections; Streptococcal Infections; Cellulitis

Interventions

ceftobiprole

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: August 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 27, 2012

Record last verified: 2012-07