Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhea: nucleic acid amplification testing (NAAT) outcomes in a randomized, multicenter phase 3 trial (EAGLE-1)

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ID: 321526
2026
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Abstract
Abstract Background The phase 3 EAGLE-1 trial demonstrated non-inferiority of oral gepotidacin to ceftriaxone plus azithromycin for treating uncomplicated urogenital gonorrhea. To reflect real-world practice, we conducted an exploratory analysis of efficacy assessed by nucleic acid amplification tests (NAAT). Methods EAGLE-1 (NCT04010539) compared the efficacy and safety of oral gepotidacin (2 x 3000 mg) with intramuscular ceftriaxone (1 x 500 mg) plus oral azithromycin (1 x 1000 mg) in participants (≥12 years) with uncomplicated urogenital gonorrhea. Urogenital specimens for NAAT were collected at baseline and test-of-cure (day 4–8). The microbiological intent-to-treat (micro-ITT) population comprised all participants who received ≥1 dose of study treatment, with culture-confirmed ceftriaxone-susceptible urogenital Neisseria gonorrhoeae at baseline. The microbiologically evaluable NAAT test-of-cure population comprised micro-ITT participants with valid baseline NAAT-positive results, who followed important trial protocol components and valid test-of-cure NAAT results. NAAT-confirmed treatment success was defined as nucleic acid clearance at test-of-cure. Results High concordance between NAAT and culture results was observed (98.4%). In the micro-ITT population, NAAT-confirmed success rates at test-of-cure were 82.5% (151/183) for gepotidacin and 75.0% (132/176) for ceftriaxone plus azithromycin (adjusted difference 8.2%, 95% confidence interval [CI], –0.1%, 16.5%); numerically lower than the corresponding culture-confirmed success rates of 92.6% (187/202) and 91.2% (186/204). In the microbiologically evaluable NAAT test-of-cure population, NAAT-confirmed success rates at test-of-cure were 88.3% (151/171) for gepotidacin and 86.3% (132/153) for ceftriaxone plus azithromycin (adjusted difference 3.8%, 95% CI, –3.6%, 11.2%). Conclusions NAAT-confirmed success rates were high and similar between treatments, supporting the primary analysis results based on culture.
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Authors W.G. Flight, Janet Wilson, David A Lewis, Jonathan Ross, Sally Gatsi, Charles Jakielaszek, Dan T Lythgoe, Salim Janmohamed, Judith Absalon, Matthew Helgeson, Caroline Perry
Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag438
URL
https://doi.org/10.1093/ofid/ofag438
Keywords Keywords not found

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