Open forum infectious diseases · 2026
Oral Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: Nucleic Acid Amplification Testing Outcomes in a Randomized, Multicenter Phase 3 Trial (EAGLE-1).
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Flight William G, Wilson Janet, Lewis David A, Ross Jonathan D C, Gatsi Sally, Jakielaszek Charles, Lythgoe Dan T, Janmohamed Salim, Absalon Judith, Helgeson Matthew, Perry Caroline
Аннотация
BACKGROUND: The phase 3 EAGLE-1 trial demonstrated noninferiority 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 × 3000 mg) with intramuscular ceftriaxone (1 × 500 mg) plus oral azithromycin (1 × 1000 mg) in participants (≥12 years) with uncomplicated urogenital gonorrhea. Urogenital specimens for NAAT were collected at baseline and test-of-cure (days 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 the 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 the 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 the 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: The NAAT-confirmed success rates were high and similar between treatments, supporting the primary analysis results based on culture.
METHODS: EAGLE-1 (NCT04010539) compared the efficacy and safety of oral gepotidacin (2 × 3000 mg) with intramuscular ceftriaxone (1 × 500 mg) plus oral azithromycin (1 × 1000 mg) in participants (≥12 years) with uncomplicated urogenital gonorrhea. Urogenital specimens for NAAT were collected at baseline and test-of-cure (days 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 the 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 the 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 the 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: The NAAT-confirmed success rates were high and similar between treatments, supporting the primary analysis results based on culture.