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A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

Trial Profile

A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2019

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At a glance

  • Drugs Tosatoxumab (Primary) ; Antibacterials
  • Indications Nosocomial pneumonia; Staphylococcal infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Aridis Pharmaceuticals
  • Most Recent Events

    • 13 Nov 2019 According to Aridis Pharmaceuticals media release, this trial presents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting.
    • 13 Nov 2019 According to an Aridis Pharmaceuticals media release, the company expects to announce top line data in early 2021.
    • 14 May 2019 According to an Aridis Pharmaceuticals media release, the Investigational New Drug (IND) application to include China among the patient enrolling countries in the study was accepted by the Chinese FDA.
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