Infection Treatment with Ceftobiprole – Phase I

Evaluation of the Single Dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics

Protocol Description

The purpose of this study is to understand how the antibiotic ceftobiprole is tolerated and processed by infants. Ceftobiprole has been tested and approved in some European countries for the treatment of pneumonia in adults.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting neonates and infants less than 3 months of age with a gestational age of at least 28 weeks who are or will be receiving intravenous antibiotic treatment for a documented or presumed bacterial infection.
Males and Females: Up to 3 months of age


Babies will receive a single dose of ceftobiprole by intravenous infusion over a 4-hour period. In a follow-up visit 3-10 days after treatment, researchers will provide a physical examination, and a small blood sample will be taken.
Visits: Up to 3
Duration: 11 days

Status: Open to Enrollment

Source(s) of Support

Basilea Pharmaceutica International

Primary Investigator

Kathleen Schwabenbauer, MD

Contact Information

For more information about the study or enrollment, please contact:
Dawn Thomas, CRN
Jessica Cagle, CRN