A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections

Trial Profile

A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2018

At a glance

  • Drugs Eravacycline (Primary) ; Meropenem
  • Indications Intra-abdominal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms IGNITE4
  • Sponsors Tetraphase Pharmaceuticals
  • Most Recent Events

    • 19 Apr 2018 According to a Tetraphase Pharmaceuticals media release, data will be presented at the 38th Annual Meeting of the Surgical Infection Society (SIS).
    • 12 Apr 2018 According to a Tetraphase Pharmaceuticals media release, the company will present data at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
    • 27 Feb 2018 According to a Tetraphase Pharmaceuticals media release, the FDA has completed its initial 60-day review of the New Drug Application (NDA) for eravacycline for the treatment of complicated intra-abdominal infections (cIAI), and determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA's review of the eravacycline NDA is set for 28 Aug 2018.
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