Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wit...
Eligibility Criteria
Inclusion
- Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
- At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells \[WBC\])
- Cardiovascular or respiratory dysfunction.
Exclusion
- Immunocompromising comorbidities or concomitant medications:
- Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
- Stage III or IV cancer.
- Haemopoietic or lymphoreticular malignancies not in remission.
- Receiving radiation therapy or chemotherapy.
- Stem cell, organ or bone marrow transplant in the past 6 months.
- Absolute neutrophil count \<500 per μL.
- High dose steroids or other immunocompromising drugs.
- Concomitant diseases:
- Deep seated fungal infection or active tuberculosis.
- Cirrhosis with portal hypertension or Childs-Pugh Class C.
- History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
- Neuromuscular disorders that impact breathing/spontaneous ventilation.
- Quadriplegia.
- Cardiac arrest in the past 30 days.
- New York Heart Association functional Class IV due to heart failure or any disorder.
- Burns over \> 30% of body surface area.
- Medication and allergy disqualifications.
- Treatment with anti-TNF agents within the last 8 weeks.
- Previously received ovine derived products (CroFab™, DigiFab™).
- Sheep product allergy or allergy to latex, papain, chymopapain.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01145560
Start Date
October 1 2010
End Date
May 1 2012
Last Update
October 6 2014
Active Locations (52)
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1
Research Site
Blacktown, New South Wales, Australia
2
Research Site
Wollongong, New South Wales, Australia
3
Research Site
Herston, Queensland, Australia
4
Research Site
Nambour, Queensland, Australia