A Study to compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) with Placebo in Adult patients with Severe Sepsis and/or Septic Shock

Exclusion Criteria

• - Immunocompromising comorbidities or concomitant medications:
• 1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
• 2. Stage III or IV cancer.
• 3. Haemopoietic or lymphoreticular malignancies not in remission.
• 4. Receiving radiation therapy or chemotherapy.
• 5. Stem cell, organ or bone marrow transplant in the past 6 months.
• 6. Absolute neutrophil count <500 per μL.
• 7. High dose steroids or other immunocompromising drugs.
• - Concomitant diseases:
• 1. Deep seated fungal infection or active tuberculosis.
• 2. Cirrhosis with portal hypertension or Childs-Pugh Class C.
• 3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
• 4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
• 5. Quadriplegia.
• 6. Cardiac arrest in the past 30 days.
• 7. New York Heart Association functional Class IV due to heart failure or any disorder.
• 8. Burns over > 30% of body surface area.
• - Medication and allergy disqualifications.
• 1. Treatment with anti-TNF agents within the last 8 weeks.
• 2. Previously received ovine derived products (CroFab™, DigiFab™).
• 3. Sheep product allergy or allergy to latex, papain, chymopapain.