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A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects

Trial Profile

A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2021

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At a glance

  • Drugs Suvratoxumab (Primary)
  • Indications Staphylococcal infections; Ventilator associated pneumonia
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms SAATELLITE
  • Sponsors AstraZeneca; MedImmune
  • Most Recent Events

    • 07 Oct 2021 Turkey and Ireland were the planned locations, according to ClinicalTrials.gov record.
    • 01 Sep 2021 Primary endpoint has not been met (Efficacy endpoint; incidence of S aureus pneumonia at 30 days, as determined by a masked independent endpoint adjudication committee (patients who received suvratoxumab 5000 mg versus those who received placebo) , according to Results published in The Lancet Infectious Diseases
    • 01 Sep 2021 According to Results published in The Lancet Infectious Diseases, based on a review of prespecified interim pharmacokinetic analysis by data monitoring committee, enrolment in Suvratoxumab 2000 mg group was discontinued 1 year after start of the trial.
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