Trial Profile
A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 01 Aug 2023
Price :
$35
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At a glance
- Drugs Sulopenem (Primary) ; Ciprofloxacin
- Indications Urinary tract infections
- Focus Registrational; Therapeutic Use
- Acronyms SURE 1
- Sponsors Iterum Therapeutics
- 19 Jun 2023 Results (n=1071) 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 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.