Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Sulopenem for the Treatment of Complicated Urinary Tract Infections Including Pyelonephritis: 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. It is linked to trial NCT03357614 (Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults), which is not on this map. Cited by 21 papers, 2 of them syntheses 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.
Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- A systematic review of data on the resistance of uropathogens to sulopenem.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Pooled it
- Novel β-lactam antibiotics versus other antibiotics for treatment of complicated urinary tract infections: a systematic review and meta-analysis.Frontiers in pharmacology · 2024Pooled it
- Patient outcomes by baseline pathogen resistance phenotype and genotype in CERTAIN-1, a Phase 3 study of cefepime-taniborbactam versus meropenem in adults with complicated urinary tract infection.Antimicrobial agents and chemotherapy · 2024Trial
- Gram-negative bacterial infection randomized controlled trials (RCTs) in the 21st century: characteristics and evolution.JAC-antimicrobial resistance · 2026Review
- What's in a Name? Etymology and History of Antibacterials and Antifungals.Open forum infectious diseases · 2026Review
- Therapeutic strategies for multi-resistantJAC-antimicrobial resistance · 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
- Profile of antimicrobial resistance of uropathogens in urinary tract infections: An analysis of 1117 hospitalized patients in Brazil.IJID regions · 2025Article
- Recent Developments in Penem Antibiotics: Structural and Therapeutic Perspectives.Molecules (Basel, Switzerland) · 2025Review
- An evaluation of antibiotic options for the treatment of biothreat pathogens.Frontiers in antibiotics · 2025Review
- 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
- Impact of antibiotic pharmacokinetics in urine on recurrent bacteriuria following treatment of complicated urinary tract infections.Antimicrobial agents and chemotherapy · 2023Article
- 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
- Antibiotics in the clinical pipeline as of December 2022.The Journal of antibiotics · 2023Review
- Applying Desirability of Outcome Ranking End Points.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Applying Desirability of Outcome Ranking End Point to Randomized Trial of Sulopenem for the Treatment of Complicated Urinary Tract Infections.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- In vitro activity of sulopenem and comparator agents against Enterobacterales and anaerobic clinical isolates collected during the SENTRY Antimicrobial Surveillance Program.The Journal of antimicrobial chemotherapy · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSulopenem is a thiopenem antibiotic being developed for the treatment of multidrug-resistant infections. The availability of both intravenous (IV) and oral formulations will facilitate earlier hospital discharge.
methodsHospitalized adults with pyuria, bacteriuria, and signs and symptoms of complicated urinary tract infection (cUTI) were randomized to 5 days of IV sulopenem followed by oral sulopenem etzadroxil/probenecid or 5 days of IV ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate, depending on uropathogen susceptibility. The primary end point was overall combined clinical and microbiologic response at the test-of-cure visit (day 21).
resultsOf 1392 treated patients, 444 and 440 treated with sulopenem and ertapenem, respectively, had a positive baseline urine culture and were eligible for the primary efficacy analyses. Extended-spectrum β-lactamase-producing organisms were identified in 26.6% of patients and fluoroquinolone-nonsusceptible pathogens in 38.6%. For the primary end point, noninferiority of sulopenem to the comparator regimen was not demonstrated, 67.8% vs 73.9% (difference, -6.1%; 95% confidence interval, -12.0 to -.1%). The difference was driven by a lower rate of asymptomatic bacteriuria in the subgroup of ertapenem-treated patients who stepped down to ciprofloxacin. No substantial difference in overall response was observed at any other time point. Both IV and oral formulations of sulopenem were well-tolerated and compared favorably to the comparator.
conclusionsSulopenem followed by oral sulopenem-etzadroxil/probenecid was not noninferior to ertapenem followed by oral step-down therapy for the treatment of cUTIs, driven by a lower rate of asymptomatic bacteriuria in those who received ciprofloxacin. Both formulations of sulopenem were well-tolerated. CLINICAL
trial registrationNCT03357614.
Indexed as
Identifiers
What OpenQuestion holds
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.