| Title: |
P-1492. Patient Characteristics Associated with Extended-Spectrum Beta-Lactamase-Producing Uropathogens: Pooled Results from Two Phase 3 Clinical Trials of Gepotidacin for the Treatment of Uncomplicated Urinary Tract Infection |
| Authors: |
Dennison, Jeremy; Sheets, Amanda; Perry, Caroline R; Wagenlehner, Florian; Wilcox, Mark H; Scangarella-Oman, Nicole E; Butler, Deborah; Breton, John; Millns, Helen; Mulgirigama, Aruni; Helgeson, Matthew; Janmohamed, Salim |
| Source: |
Open Forum Infectious Diseases ; volume 12, issue Supplement_1 ; ISSN 2328-8957 |
| Publisher Information: |
Oxford University Press (OUP) |
| Publication Year: |
2025 |
| Description: |
Background Uncomplicated urinary tract infections (uUTIs), usually caused by Escherichia coli (E. coli), are common infections, affecting ∼50% of women globally in their lifetime. The presence of extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales limits effective oral treatment options for uUTI. Using uropathogen susceptibility data from two randomized controlled trials (RCTs) in uUTI, we compared baseline characteristics of patients with ESBL-positive (ESBL+) versus non-ESBL uropathogens. Methods EAGLE-2 (NCT04020341) and -3 (NCT04187144) were Phase 3, double-blind RCTs of oral gepotidacin versus nitrofurantoin for uUTI. Patients were female, aged ≥ 12 years, with ≥ 2 uUTI symptoms and urinary nitrite and/or pyuria. Pretreatment clean-catch midstream urine samples were collected for quantitative culture and susceptibility. In this post-hoc exploratory analysis, patients in the intent-to-treat population (all randomized patients), with ≥ 103 colony-forming units/mL E. coli, Klebsiella pneumoniae, Klebsiella oxytoca, and/or Proteus mirabilis, were grouped by ESBL status of their uropathogen(s), per Clinical and Laboratory Standards Institute guidelines. Results Overall, 1423 patients with culture-confirmed uUTI were included in the analysis; 203 (14%) had an ESBL+ uropathogen. Baseline characteristics by ESBL status are presented in the Table, and ESBL+ uropathogen prevalence by subgroup in the Figure. Generally, versus patients with non-ESBL uropathogens, more patients with ESBL+ uropathogens were: of Asian, American Indian or Alaska Native race (though sample sizes were small); of Hispanic/Latinx ethnicity; had milder symptoms; aged > 50 years with history of recurrent urinary tract infection. Conclusion This post-hoc analysis of contemporary uUTI trial data describes baseline characteristics for patients with ESBL+ versus non-ESBL uropathogens. These data could inform future studies to identify clinical risk factors linked to ESBL+ uropathogens and improve patient outcomes. ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1093/ofid/ofae631.1662 |
| Availability: |
https://doi.org/10.1093/ofid/ofae631.1662; https://academic.oup.com/ofid/article-pdf/12/Supplement_1/ofae631.1662/61681554/ofae631.1662.pdf |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.7F277602 |
| Database: |
BASE |