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
Price :
$35
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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
- 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.