Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

Summary

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

Timeline

Start

2018-08-01

Primary completion

2020-01-16

Completion

2020-01-20

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper In the nonsusceptible population, sulopenem was superior to ciprofloxacin, 62.6% vs 36.0% (difference, 26.6%; 95% confidence interval [CI], 15.1 to 7.4; P <.001). reads as mixed primary results PMID 36069202 ↗

paper In the susceptible population, sulopenem was not noninferior to ciprofloxacin, 66.8% vs 78.6% (difference, -11.8%; 95% CI, -18.0 to 5.6). reads as mixed primary results PMID 36069202 ↗

release “The SURE-1 clinical trial (uUTIs) demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint” reads as met primary endpoint iterumtx.com ↗

Publications

• Dunne MW, Aronin SI, Das AF, Akinapelli K, Zelasky MT, Puttagunta S, Boucher HW. Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):66-77. doi: 10.1093/cid/ciac738.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ciprofloxacin	Small molecule	250 mg	Oral
Subject	Sulopenem	Small molecule	—	Oral
Background	Probenecid	Small molecule	—	Oral

Indications