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Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults

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Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2023

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At a glance

  • Drugs Sulopenem (Primary) ; Sulopenem (Primary) ; Amoxicillin/clavulanic acid; Ciprofloxacin; Ertapenem
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SURE 2
  • Sponsors Iterum Therapeutics

    • Most Recent Events

    • 19 Jun 2023 Results (n=884) characterizing the beta lactamase content of select; Enterobacterales isolates recovered from patients enrolled in this trial presented at the ASM Microbe 2023
    • 07 Sep 2022 Results assessing efficacy of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults, published in the Clinical Infectious Diseases.
    • 12 Nov 2021 According to an Iterum Therapeutics media release, the company has requested a Type B meeting with the FDA to discuss the design of a potential new clinical trial to support such potential resubmission.

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