Evidence map›Paper›PMID 42517149›Full record

ArticleOpen forum infectious diseases2026

Oral Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: Nucleic Acid Amplification Testing Outcomes in a Randomized, Multicenter Phase 3 Trial (EAGLE-1).

William G Flight, Janet Wilson, David A Lewis, Jonathan D C Ross, Sally Gatsi, Charles Jakielaszek, Dan T Lythgoe, Salim Janmohamed, Judith Absalon, Matthew Helgeson and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04010539 (A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04010539 phase3completednot on this map

A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae

TypeinterventionalSponsorGlaxoSmithKlineRan2019 to 2023Enrolled628ConditionsGonorrheaArmsGepotidacin, Ceftriaxone, Azithromycin
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

William G FlightGSK, London, UK.ORCID https://orcid.org/0000-0003-3343-4211
Janet WilsonThe Leeds Teaching Hospitals NHS Trust, Leeds, UK.
David A LewisSydney Medical School-Westmead, University of Sydney, Sydney, New South Wales, Australia.
Jonathan D C RossUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Sally GatsiOrganon LLC, Jersey City, New Jersey, USA.
Charles JakielaszekGSK, Collegeville, Pennsylvania, USA.
Dan T LythgoeGSK, Stevenage, UK.
Salim JanmohamedGSK, London, UK.
Judith AbsalonGSK, Collegeville, Pennsylvania, USA.
Matthew HelgesonGSK, Collegeville, Pennsylvania, USA.
Caroline PerryGSK, Collegeville, Pennsylvania, USA.ORCID https://orcid.org/0000-0001-6387-319X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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). 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 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.

Indexed as

EAGLE-1gepotidacingonorrheaNAATNeisseria gonorrhoeae

Identifiers

PMID42517149
PMCPMC13403078

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.