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)
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
- 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.