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First received: April 17, 2023

Clinical Trial: Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

Study Status: Completed

Recruit Status: RECRUITING

Condition: Neonatal Sepsis

Study Type: INTERVENTIONAL


Official Title: A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of

Brief Summary: This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'.It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

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