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A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/tazobactam Compared With Meropenem in Adult Patients with Ventilated Nosocomial Pneumonia

Trial Profile

A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/tazobactam Compared With Meropenem in Adult Patients with Ventilated Nosocomial Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Ceftolozane/tazobactam (Primary) ; Meropenem
  • Indications Nosocomial pneumonia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASPECT-NP
  • Sponsors Cubist Pharmaceuticals
  • Most Recent Events

    • 03 Jun 2019 Results presented in a Merck & Co media release.
    • 03 Jun 2019 Based on the result of this study, the the U.S. Food and Drug Administration (FDA) has approved supplemental New Drug Application (sNDA) for ceftolozane/tazobactam for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia caused by certain susceptible Gram-negative bacteria in adult patients.
    • 30 Apr 2019 According to Merck and Co media release, data from this trial were presented at the European Congress of Clinical Microbiology & Infectious Diseases.
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