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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins

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)