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A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety, pharmacokinetics, and efficacy of ceftobiprole medocaril in term and preterm neonates and infants up to 3 months of age with late-onset sepsis

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Trial Profile

A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety, pharmacokinetics, and efficacy of ceftobiprole medocaril in term and preterm neonates and infants up to 3 months of age with late-onset sepsis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2024

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At a glance

  • Drugs Ceftobiprole medocaril (Primary)
  • Indications Sepsis
  • Focus Adverse reactions; Registrational
  • Sponsors Basilea Pharmaceutica International

Most Recent Events

  • 20 Dec 2024 Status changed from recruiting to completed.
  • 13 Sep 2024 Planned number of patients changed from 15 to 9.
  • 09 Jan 2024 Planned End Date changed from 1 Dec 2023 to 1 Dec 2024.

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