Trial Profile

A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 23 Jan 2025

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At a glance

Drugs Cefiderocol (Primary)
Indications Aerobic infections; Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Septicaemia; Urinary tract infections; Ventilator associated pneumonia
Focus Adverse reactions; Pharmacokinetics
Acronyms PEDI-CEFI
Sponsors Shionogi

09 Mar 2023 Status changed from recruiting to completed.
08 Mar 2023 This trial has been completed in Hungary (End Date: 6 Feb 2023) according to European Clinical Trials Database record.
16 Jan 2023 Planned End Date changed from 15 Dec 2022 to 28 Feb 2023.

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