A pivotal, double-blind, double-dummy, non-inferiority trial Phase III clinical trial of SPR994 with IV ertapenem as a comparator in patients with complicated urinary tract infections (cUTI)

Trial Profile

A pivotal, double-blind, double-dummy, non-inferiority trial Phase III clinical trial of SPR994 with IV ertapenem as a comparator in patients with complicated urinary tract infections (cUTI)

Planning
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2018

At a glance

  • Drugs Tebipenem pivoxil (Primary) ; Ertapenem
  • Indications Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Spero Therapeutics
  • Most Recent Events

    • 09 Jul 2018 According to a Spero Therapeutics media release, the company intend to initiate the trial around year-end 2018 subject to feedback from the FDA in a pre-Phase 3 meeting
    • 02 Apr 2018 According to a Spero Therapeutics media release, company plans to initiate this trial around year-end 2018 in support of a new drug application (NDA).
    • 14 Dec 2017 According to a Spero Therapeutics media release, based on the results of phase 1 (289607) clinical trial, the company expects to commence this phase 3 trial of SPR994 to treat patients with Urinary tract infections.
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