An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia

Trial Profile

An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2017

At a glance

  • Drugs Solithromycin (Primary) ; Azithromycin; Ceftriaxone
  • Indications Gonorrhoea
  • Focus Registrational; Therapeutic Use
  • Acronyms SOLITAIRE-U
  • Sponsors Cempra Pharmaceuticals
  • Most Recent Events

    • 08 Sep 2017 Status changed from recruiting to completed.
    • 27 Jun 2017 Planned End Date changed from 1 Apr 2017 to 1 Aug 2017.
    • 27 Jun 2017 Planned primary completion date changed from 1 Apr 2017 to 1 Aug 2017.
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