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A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults

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Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2025

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At a glance

  • Drugs Aztreonam (Primary) ; Cefepime (Primary) ; Nacubactam (Primary) ; Imipenem/cilastatin
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Integral-1
  • Sponsors Meiji Seika Pharma

Most Recent Events

  • 14 Mar 2025 According to Meiji Seika Pharma media release, company announced Positive Results of Global Phase III Clinical Trial of OP0595, a Novel beta Lactamase Inhibitor for Combating Antimicrobial Resistance (AMR), in Patients with Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
  • 14 Mar 2025 According to Meiji Seika Pharma media release, Primary endpoint (The primary efficacy endpoint is the proportion of patients who achieve composite clinical and microbiological success at TOC in the Microbiological Modified Intent-to-Treat (m-MITT) Population) has been met.
  • 14 Mar 2025 Results published in theMeiji Seika Pharma media release

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