The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Ventilator-free Days (VFDs) Over 28 Days
Number of ventilator-free days (VFDs)
Time frame: Over 28 days following first dose
7-day Mortality
Number of patients who died over 7 days
Time frame: Over 7 days following first dose
28-day Mortality
Number of patients who died over 28 days
Time frame: Over 28 days following first dose
Safety and Tolerability
Number of patients with treatment-emergent adverse events
Time frame: All study visits (over 90 days following first dose)
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Research Site
Blacktown, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Herston, Queensland, Australia
Research Site
Nambour, Queensland, Australia
Research Site
Woollongabba, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Footscray, Victoria, Australia
Research Site
Fremantle, Western Australia, Australia
Research Site
Antwerp, Belgium, Belgium
...and 42 more locations