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Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of ZTI-01 vs Piperacillin/Tazobactam in the Treatment of cUTI/AP Infection in Hospitalized Adults

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Trial Profile

Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of ZTI-01 vs Piperacillin/Tazobactam in the Treatment of cUTI/AP Infection in Hospitalized Adults

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 31 Jul 2024

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At a glance

  • Drugs Fosfomycin (Primary) ; Piperacillin/tazobactam
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ZEUS
  • Sponsors Zavante Therapeutics

Most Recent Events

  • 18 Jul 2024 According to a Meitheal Pharmaceuticals media release, the company has submitted the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for the approval of CONTEPO™ (fosfomycin for injection) for the treatment of cUTI, including acute pyelonephritis. A decision is expected from the FDA later this year.
  • 29 Aug 2022 Results of an analysis assessed the Desirability of outcome ranking (DOOR) approach application to Improving traditional registrational trial endpoints applied to three registrational drug trials (ZEUS, APEKS-cUTI, and DORI-05) published in the Clinical Infectious Diseases
  • 05 Apr 2021 According to a Nabriva Therapeutics media release, this extension provides the Agency adequate time to assess the application of the recently issued guidance entitled "Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19" to the CONTEPO re-submission.

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