Conditions: Severe Sepsis Septic Shock
Keywords: severe sepsis TNF neutralisation septic shock patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: AZD9773 250/50 units/kg arm 2: AZD9773 500/100 units/kg arm 3: None

Interventions: intervention 1: AZD9773 intervention 2: Placebo
Intervention descriptions: intervention 1: A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days intervention 2: Placebo

Protocol document: