Oral Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: Nucleic Acid Amplification Testing Outcomes in a Randomized, Multicenter Phase 3 Trial (EAGLE-1)
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
Abstract 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). s1 Methods EAGLE-1 () 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 urogenitalat 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. s2 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 co
Abstract
Abstract 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). s1 Methods EAGLE-1 () 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 urogenitalat 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. s2 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%). s3 Conclusions The NAAT-confirmed success rates were high and similar between treatments, supporting the primary analysis results based on culture. s4 Urogenital gonorrhea treatment success rates by NAAT were high and similar between gepotidacin and ceftriaxone plus azithromycin, supporting primary analysis results based on microbiological culture. Therefore, NAAT may be a promising complement to culture in future clinical trials. teaser