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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2023

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At a glance

  • Drugs Tosatoxumab (Primary) ; Antibacterials
  • Indications Staphylococcal infections; Ventilator associated pneumonia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASAP-1
  • Sponsors Aridis Pharmaceuticals

    • Most Recent Events

    • 21 Oct 2023 This trial has been completed in Spain according to European Clinical Trials Database record.
    • 12 Jul 2023 According to an Aridis Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation under the Generating Antibiotic Incentives Now (GAIN) Act for AR-301, currently in Phase 3 clinical development as an adjunctive therapy for pneumonia caused by gram-positive Staphylococcus aureus in critically ill hospitalized patients.
    • 14 Mar 2023 Status changed from active, no longer recruiting to completed, according to a Aridis Pharmaceuticals media release.
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