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Be Part of Research - Trial Details - A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
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A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Completed

Open to: ALL

Age: 12.0 - N/A

Brighton Manchester Birmingham London London Leeds London Edinburgh London Reading St Helens

Medical Conditions

Gonorrhea

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2019 Oct 2023

Publications

"Ross JDC, Wilson J, Workowski KA, Taylor SN, Lewis DA, Gatsi S, Flight W, Scangarella-Oman NE, Jakielaszek C, Lythgoe D, Powell M, Janmohamed S, Absalon J, Perry C. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025 May 3;405(10489):1608-1620. doi: 10.1016/S0140-6736(25)00628-2. Epub 2025 Apr 14."; "40245902"; "Perry CR, Scangarella-Oman NE, Millns H, Flight W, Gatsi S, Jakielaszek C, Janmohamed S, Lewis DA. Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study. Infect Dis Ther. 2023 Sep;12(9):2307-2320. doi: 10.1007/s40121-023-00862-6. Epub 2023 Sep 26."; "37751016"; "Fishman C, Caverly Rae JM, Posobiec LM, Laffan SB, Lerman SA, Pearson N, Janmohamed S, Dumont E, Nunn-Floyd D, Stanislaus DJ. Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats. Antimicrob Agents Chemother. 2022 Nov 15;66(11):e0048322. doi: 10.1128/aac.00483-22. Epub 2022 Oct 18."; "36255258"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water.

Intervention Arm Group : Participants receiving Gepotidacin;

Intervention Type : DRUG
Intervention Description : Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.

Intervention Arm Group : Participants receiving Ceftriaxone plus Azithromycin;

Intervention Type : DRUG
Intervention Description : Azithromycin will be administered as 1000 mg oral dose (2 X 500 mg tablets) at the study site. Dose should be taken after food consumption and with water.

Intervention Arm Group : Participants receiving Ceftriaxone plus Azithromycin;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • GSK Investigational Site
    Brighton
    BN2 1ES
  • GSK Investigational Site
    Manchester
    M13 0FH
  • GSK Investigational Site
    Birmingham
    B4 6DH
  • GSK Investigational Site
    London
    W2 1NY
  • GSK Investigational Site
    London
    WC1E 6JB
  • GSK Investigational Site
    Leeds
    LS1 3EX
  • GSK Investigational Site
    London
    E9 6SR
  • GSK Investigational Site
    Edinburgh
    EH3 9ES
  • GSK Investigational Site
    London
    W6 7AL
  • GSK Investigational Site
    Reading
    RG1 5SL
  • GSK Investigational Site
    St Helens
    WA9 3DA


The study is sponsored by GlaxoSmithKline



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Read full details for Trial ID: NCT04010539
Last updated 01 May 2024

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