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A Phase III, Pivotal Study of Fixed-Dose Combination of ETX2514 and Sulbactam (Sulbactam/ETX-2514) for the Treatment of Carbapenem-Resistant Acinetobacter baumannii Infections

Trial Profile

A Phase III, Pivotal Study of Fixed-Dose Combination of ETX2514 and Sulbactam (Sulbactam/ETX-2514) for the Treatment of Carbapenem-Resistant Acinetobacter baumannii Infections

Planning
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2019

At a glance

  • Drugs Sulbactam/ETX 2514 (Primary)
  • Indications Acinetobacter infections
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 05 Feb 2019 According to the Entasis Therapeutics media release, company announced an agreement with bioMerieux to incorporate the BIOFIRE FILMARRAY instruments and BIOFIRE FILMARRAY Pneumonia panels into the trial for enrollment optimization.
    • 05 Feb 2019 According to the Entasis Therapeutics media release, company received positive feedback from the U.S. Food and Drug Administration (FDA) End-of-Phase 2 meeting regarding ETX2514SUL for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii.
    • 14 Aug 2018 According to an Entasis Therapeutics media release, the company plans to initiate this phase 3 trial focusing on carbapenem-resistant Acinetobacter baumannii infections in the first quarter of 2019.
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