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A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Meropenem Followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), Including Acute Pyelonephritis (AP), in Adults

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Trial Profile

A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Meropenem Followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), Including Acute Pyelonephritis (AP), in Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jun 2025

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At a glance

  • Drugs Plazomicin (Primary) ; Levofloxacin; Meropenem
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIC
  • Sponsors Achaogen

Most Recent Events

  • 20 May 2025 According to a Cipla media release, ZEMDRI (Plazomicin) has been launched in India, and its approval was based on the data from this study.
  • 28 Mar 2019 According to an Achaogen media release, the Company has received the Day 120 List of Questions from the European Medicines Agency (EMA) as part of the centralized review process of the MAA for plazomicin.
  • 21 Feb 2019 The New England Journal of Medicine has published the results from this trial, as reported in an Achaogen media release.

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