{
  "abstract": "Background: Two phase 3 trials (EAGLE-2 [NCT04020341]/EAGLE-3 [NCT04187144]) demonstrated the efficacy of gepotidacin, a novel, first-in-class triazaacenaphthylene antibacterial, versus nitrofurantoin for the treatment of uncomplicated urinary tract infections (uUTIs). Using pooled data, we assessed gepotidacin efficacy across clinically important subgroups, including participants with nitrofurantoin not-susceptible (NTF-NS; ie, resistant, intermediate or no interpretation) uropathogens.\n\nMethods: Female participants aged ≥12 years with uUTI received gepotidacin (1500 mg) or nitrofurantoin (100 mg), both twice daily for 5 days. Therapeutic success at test-of-cure (day 10–13) was defined as combined complete symptom resolution (clinical success) and reduction of baseline qualifying uropathogens from ≥105 to <103 CFU/mL (microbiological success), without other systemic antibacterials. Response rates at test-of-cure were descriptively summarized in the pooled microbiological intent-to-treat (micro-ITT) nitrofurantoin-susceptible (NTF-S) and NTF-NS populations, and across prespecified subgroups.\n\nResults: In the micro-ITT NTF-S population, treatment differences (in favor of gepotidacin) [95% confidence interval] for therapeutic, clinical and microbiological success were: 9.6% [4.1, 15.2], 2.8% [−2.4, 8.1], and 10.4% [5.2, 15.6]. Corresponding treatment differences were higher in the micro-ITT NTF-NS population: 20.8% [9.2, 32.4], 10.3% [−1.4, 22.1], 20.7% [9.2, 32.3]. In both of these populations, gepotidacin success rates (all endpoints) were similar to or higher than nitrofurantoin across prespecified subgroups at higher risk for antimicrobial resistant uropathogens (age >50 years, history of recurrent uUTI, diabetes, mild renal impairment, extended-spectrum β-lactamase-producing or fluoroquinolone-resistant uropathogens).\n\nConclusions: Gepotidacin demonstrated efficacy with generally higher therapeutic success rates versus nitrofurantoin in participants with NTF-S and NTF-NS uropathogens, and across a range of key subgroups.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "name": "Amanda Sheets"
    },
    {
      "name": "Jeremy Dennison",
      "orcid": "0000-0002-0063-0614"
    },
    {
      "name": "Jennifer H Han",
      "orcid": "0000-0003-4744-8067"
    },
    {
      "name": "Sarah Watts"
    },
    {
      "name": "Caroline Perry",
      "orcid": "0000-0001-6387-319X"
    },
    {
      "name": "Nicole E Scangarella-Oman",
      "orcid": "0000-0003-4211-8261"
    },
    {
      "name": "Deborah Butler"
    },
    {
      "name": "John Breton",
      "orcid": "0000-0001-7989-5465"
    },
    {
      "name": "Thomas M Hooton",
      "orcid": "0000-0001-5810-6543"
    },
    {
      "name": "Helen Millns"
    },
    {
      "name": "Matthew Helgeson"
    },
    {
      "name": "Salim Janmohamed"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/b5fd846jwvsgy.bib",
  "cited_by": 0,
  "doi": "10.1093/cid/ciag408",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13715975/",
  "id": "b5fd846jwvsgy",
  "issns": [
    "1058-4838",
    "1537-6591"
  ],
  "landing_url": "https://doi.org/10.1093/cid/ciag408",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "AcademicSubjects/MED00290"
    ],
    [
      "heading",
      "Bacterial Infections"
    ],
    [
      "heading",
      "Major Article"
    ],
    [
      "openalex",
      "2713|Urinary Tract Infections Management"
    ]
  ],
  "openalex": "W7167596863",
  "pdf_url": null,
  "pmcid": "PMC13715975",
  "pmid": "42413960",
  "published": "2026-07-08",
  "publisher": "Oxford University Press",
  "ris": "https://research.draconitic.com/paper/b5fd846jwvsgy.ris",
  "sources": [
    {
      "first_seen": "2026-11-01T12:23:08Z",
      "native_id": "PMC13715975",
      "source": "pmc",
      "url": "https://doi.org/10.1093/cid/ciag408"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2713|Urinary Tract Infections Management",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Subgroup Analysis of Pooled Phase 3 Efficacy Data From Two Randomized Trials of Gepotidacin Versus Nitrofurantoin in Uncomplicated Urinary Tract Infections (EAGLE-2 and EAGLE-3) Including Participants With Uropathogens Not-Susceptible to Nitrofurantoin",
  "title_text": "Subgroup Analysis of Pooled Phase 3 Efficacy Data From Two Randomized Trials of Gepotidacin Versus Nitrofurantoin in Uncomplicated Urinary Tract Infections (EAGLE-2 and EAGLE-3) Including Participants With Uropathogens Not-Susceptible to Nitrofurantoin",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:23:08Z",
  "url": "https://research.draconitic.com/paper/b5fd846jwvsgy",
  "venue": "Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America",
  "versions": []
}