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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia

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Trial Profile

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2020

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At a glance

  • Drugs Amikacin (Primary) ; Antibacterials
  • Indications Gram-negative infections; Nosocomial pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms INHALE-1
  • Sponsors Bayer
  • Most Recent Events

    • 24 Nov 2017 According to a Bayer media release, the primary as well as secondary endpoints of the INHALE phase III program were not met. Efficacy and safety analyses from this study will be published in due course.
    • 05 May 2017 Status changed from recruiting to completed.
    • 01 Mar 2017 According to a Nektar Therapeutics media release, top-line data from the INHALE phase III programare expected in the middle of 2017.
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