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A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea

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Trial Profile

A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2023

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At a glance

  • Drugs Zoliflodacin (Primary) ; Azithromycin; Ceftriaxone
  • Indications Gonococcal urethritis; Gonorrhoea
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 01 Nov 2023 According to an Innoviva media release, Primary endpoint (Efficacy of a single dose of zoliflodacin will be assessed compared to a combination of a single dose of ceftriaxone and azithromycin.) has been met.
    • 01 Nov 2023 According to an Innoviva media release, company announced positive topline data from this zoliflodacin data for treatment of gonorrhea in November 2023.
    • 02 Aug 2023 According to an Innoviva media release, topline results are expected in late 2023.
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