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: 17 Aug 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

    • 17 Aug 2017 According to a Tetraphase Pharmaceuticals media release, based on the data from this study, the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA).
    • 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.
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