{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T11:58:59Z","timestamp":1785153539312,"version":"3.55.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":16,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002066","name":"GSK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002066","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority","award":["HHSO100201300011C"],"award-info":[{"award-number":["HHSO100201300011C"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>EAGLE-1 (NCT04010539) compared the efficacy and safety of oral gepotidacin (2 \u00d7 3000\u2005mg) with intramuscular ceftriaxone (1 \u00d7 500\u2005mg) plus oral azithromycin (1 \u00d7 1000\u2005mg) in participants (\u226512 years) with uncomplicated urogenital gonorrhea. Urogenital specimens for NAAT were collected at baseline and test-of-cure (days 4\u20138). The microbiological intent-to-treat (micro-ITT) population comprised all participants who received \u22651 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\u2013confirmed treatment success was defined as nucleic acid clearance at the test-of-cure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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], \u22120.1%, 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, \u22123.6%, 11.2%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The NAAT-confirmed success rates were high and similar between treatments, supporting the primary analysis results based on culture.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofag438","type":"journal-article","created":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T11:51:42Z","timestamp":1784116302000},"source":"Crossref","is-referenced-by-count":0,"title":["Oral Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: Nucleic Acid Amplification Testing Outcomes in a Randomized, Multicenter Phase 3 Trial (EAGLE-1)"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3343-4211","authenticated-orcid":false,"given":"William G","family":"Flight","sequence":"first","affiliation":[{"name":"GSK , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"Wilson","sequence":"additional","affiliation":[{"name":"The Leeds Teaching Hospitals NHS Trust , Leeds ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Lewis","sequence":"additional","affiliation":[{"name":"Sydney Medical School\u2014Westmead, University of Sydney , Sydney, New South Wales ,","place":["Australia"]},{"name":"Western Sydney Local Health District, Western Sydney Sexual Health Centre , Sydney, New South Wales ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan D C","family":"Ross","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust , Birmingham ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sally","family":"Gatsi","sequence":"additional","affiliation":[{"name":"Organon LLC , Jersey City, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Jakielaszek","sequence":"additional","affiliation":[{"name":"GSK, Collegeville , Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan T","family":"Lythgoe","sequence":"additional","affiliation":[{"name":"GSK , Stevenage ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salim","family":"Janmohamed","sequence":"additional","affiliation":[{"name":"GSK , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Absalon","sequence":"additional","affiliation":[{"name":"GSK, Collegeville , Pennsylvania 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