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A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection Due to Carbapenem Resistant Enterobacterales

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Trial Profile

A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection Due to Carbapenem Resistant Enterobacterales

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 May 2025

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At a glance

  • Drugs Aztreonam (Primary) ; Cefepime (Primary) ; Nacubactam (Primary) ; Amikacin; Cilastatin; Colistimethate sodium; Imipenem; Relebactam; Tigecycline
  • Indications Bacterial infections; Intra-abdominal infections; Nosocomial pneumonia; Pyelonephritis; Urinary tract infections; Ventilator associated pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms Integral-2
  • Sponsors Meiji Seika Pharma

Most Recent Events

  • 09 May 2025 Planned End Date changed from 1 Feb 2025 to 1 Sep 2025.
  • 09 May 2025 Planned primary completion date changed from 1 Feb 2025 to 1 Sep 2025.
  • 10 May 2023 New trial record

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