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

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2017

At a glance

  • Drugs Eravacycline (Primary) ; Ertapenem
  • Indications Bacterial infections; Intra-abdominal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms IGNITE 1
  • Sponsors Tetraphase Pharmaceuticals
  • Most Recent Events

    • 25 Jul 2017 According to a Tetraphase Pharmaceuticals media release, based on the data from IGNITE1 and IGNITE4 studies company plans to submit NDA for IV eravacycline for the treatment of patients with complicated intra-abdominal infections (cIAI) in first quarter of 2018.
    • 03 Apr 2017 According to a company media release, Tetraphase Pharmaceuticals plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) in the third quarter of 2017 based on the data from this trial.
    • 19 Dec 2016 According to a Tetraphase Pharmaceuticals media release, company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for IV eravacycline for the treatment of cIAI during the second half of 2017 based on the data from this trial.
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