Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3, Randomized Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03354598 (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), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Definitions and rates of treatment failure in females with uncomplicated urinary tract infection: a systematic literature review.The Journal of antimicrobial chemotherapy · 2026Pooled it
- Sulopenem for the Treatment of Complicated Urinary Tract Infections Including Pyelonephritis: A Phase 3, Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- When Empiric Therapy Fails: Clinical and Economic Consequences in uUTIs Among US Women.Microorganisms · 2026Article
- Article
- Uncomplicated Urinary Tract Infections: From an Invisible Impact to a Visible Change in Complex Care.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Antibiotic Stewardship in Pediatric Urinary Tract Infections: Current Evidence and Practical Strategies.Antibiotics (Basel, Switzerland) · 2026Review
- What's Hot This Year in ID Clinical Science 2025.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Review
- The oral penems and carbapenems.Clinical microbiology reviews · 2025Review
- Prevalence and economic evaluation of acute uncomplicated cystitis in women from Japan: a retrospective cohort study.JAC-antimicrobial resistance · 2025Article
- The Current Landscape of Antibiotic Use and Antimicrobial Resistance in Japan: Focusing on Common Infections Including Uncomplicated Urinary Tract Infection and Gonorrhea.Antibiotics (Basel, Switzerland) · 2025Review
- Review
- Recent Developments in Penem Antibiotics: Structural and Therapeutic Perspectives.Molecules (Basel, Switzerland) · 2025Review
- A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2024.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- Characterization of sulopenem antimicrobial activity usingMicrobiology spectrum · 2025Article
- New Agents Are Coming, and So Is the Resistance.Antibiotics (Basel, Switzerland) · 2024Review
- A pairwise approach to revitalize β-lactams for the treatment of TB.Antimicrobial agents and chemotherapy · 2024Article
- What's Hot This Year in Infectious Diseases Clinical Science.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Review
- Evaluation of Oral Amoxicillin/Clavulanate for Urinary Tract Infections Caused by Ceftriaxone Non-Susceptible Enterobacterales.Pharmacy (Basel, Switzerland) · 2024Article
- Review
- Impact of acquired broad-spectrum β-lactamases on susceptibility to oral penems/carbapenems (tebipenem, sulopenem, and faropenem) alone or in combination with avibactam and taniborbactam β-lactamase inhibitors inAntimicrobial agents and chemotherapy · 2023Article
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere are limited treatment options for uncomplicated urinary tract infection (uUTI) caused by resistant pathogens. Sulopenem etzadroxil/probenecid (sulopenem) is an oral thiopenem antibiotic active against multidrug-resistant pathogens that cause uUTIs.
methodsPatients with uUTI were randomized to 5 days of sulopenem or 3 days of ciprofloxacin. The primary endpoint was overall success, defined as both clinical and microbiologic response at day 12. In patients with ciprofloxacin-nonsusceptible baseline pathogens, sulopenem was compared for superiority over ciprofloxacin; in patients with ciprofloxacin-susceptible pathogens, the agents were compared for noninferiority. Using prespecified hierarchical statistical testing, the primary endpoint was tested in the combined population if either superiority or noninferiority was declared in the nonsusceptible or susceptible population, respectively.
resultsIn 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). 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). The difference was driven by a higher rate of asymptomatic bacteriuria (ASB) post-treatment in patients on sulopenem. In the combined analysis, sulopenem was noninferior to ciprofloxacin, 65.6% vs 67.9% (difference, -2.3%; 95% CI, -7.9 to 3.3). Diarrhea occurred more frequently with sulopenem (12.4% vs 2.5%).
conclusionsSulopenem was noninferior to ciprofloxacin in the treatment of uUTIs. Sulopenem was superior to ciprofloxacin in patients with uUTIs due to ciprofloxacin-nonsusceptible pathogens. Sulopenem was not noninferior in patients with ciprofloxacin-susceptible pathogens, driven largely by a lower rate of ASB in those who received ciprofloxacin. CLINICAL
trial registrationNCT03354598.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.