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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: 07 Jan 2022

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At a glance

  • Drugs Amikacin (Primary) ; Antibacterials
  • Indications Gram-negative infections; Ventilator associated pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms INHALE-2
  • Sponsors Bayer

Most Recent Events

  • 11 Jun 2019 I have retained status as per NCT. Kindly update further.
  • 07 Dec 2017 This trial has been completed in Belgium, according to European Clinical Trials Database.
  • 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.

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