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An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

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Trial Profile

An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Cefiderocol (Primary) ; Antibacterials
  • Indications Aerobic infections; Bacterial infections; Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Pneumonia; Sepsis; Urinary tract infections; Ventilator associated pneumonia
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms APEKS-PEDI
  • Sponsors Shionogi

Most Recent Events

  • 15 Oct 2024 Status changed from active, no longer recruiting to completed.
  • 10 Sep 2024 Status changed from recruiting to active, no longer recruiting.
  • 04 Jun 2024 Planned End Date changed from 15 Jun 2024 to 30 Sep 2024.

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