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An Open-label, Multicenter, Single-arm, Phase 1 Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects With Known or Suspected Bacterial Pneumonia on Treatment With Standard of Care Antibiotics and Requiring Mechanical Ventilation

Trial Profile

An Open-label, Multicenter, Single-arm, Phase 1 Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects With Known or Suspected Bacterial Pneumonia on Treatment With Standard of Care Antibiotics and Requiring Mechanical Ventilation

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 21 Oct 2021

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At a glance

  • Drugs Cefiderocol (Primary) ; Antibacterials
  • Indications Bacterial infections; Nosocomial pneumonia; Pneumonia
  • Focus Pharmacokinetics
  • Sponsors Shionogi
  • Most Recent Events

    • 14 Oct 2021 Data from studies (NCT03862040, NCT03032380 NCT02714595) used to develop an intrapulmonary pharmacokinetic model of cefiderocol and assess pharmacokinetic profile in lungs published in the Journal of Clinical Pharmacology
    • 12 Aug 2021 Results published in the Journal of Antimicrobial Chemotherapy
    • 25 Oct 2020 Results assessing intrapulmonary pharmacokinetics of Cefiderocol in hospitalized and ventilated patients receiving standard of care antibiotics for bacterial pneumonia presented at the IDWeek 2020

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