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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.
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
Basilea Pharmaceutica International
Study Description at National Institutes of Health
Newborn Medicine Research
Kathleen Schwabenbauer, MD
For more information about the study or enrollment, please contact:
Dawn Thomas, CRN
Jessica Cagle, CRN
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One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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