CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9 enrolled
Drug / intervention
Ceftobiprole medocarildrug
Likely dose
Ceftobiprole medocaril 7.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05856227
NCT05856227Phase 3Completed
CompareCT.gov

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 Age With Late-onset Sepsis

Basilea Pharmaceutica·interventional·Posted May 12, 2023·Updated Jul 28, 2025

In Brief

A Phase 3 clinical trial evaluating Ceftobiprole medocaril for Neonatal Sepsis. Completed, enrolled 9 participants across 14 sites in 8 countries.

Detailed Summary

This study evaluated 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Sepsis
CountriesBulgaria, Estonia, Germany, Latvia, Lithuania, Poland, Slovakia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedMay 12, 2023
Enrollment StartAug 6, 2023
Primary CompletionDec 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.1 years ago

Interventions

Ceftobiprole medocarildrug

Ceftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion.