Status:
COMPLETED
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
Lead Sponsor:
AstraZeneca
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and ...
Eligibility Criteria
Inclusion
- Japanese 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).
- Haemopoietic or lymphoreticular malignancies not in remission.
- Receiving radiation therapy or chemotherapy.
- Any organ or bone marrow transplant within the past 24 weeks.
- Absolute neutrophil count \<500 per μL.
- High dose steroids or other immunocompromising drugs.
- Concomitant diseases:
- Deep-seated fungal infection or active tuberculosis.
- Severe chronic liver disease associated with portal hypertension, cirrhosis, chronic ascites or Child-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 III or IV due to heart failure or any disorder.
- Burns over \> 30% of body surface area in the past 5 days.
- 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 papain, chymopapain.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01144624
Start Date
July 1 2010
End Date
August 1 2011
Last Update
October 6 2014
Active Locations (7)
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1
Research Site
Sapporo, Hokkaido, Japan
2
Research Site
Kobe, Hyōgo, Japan
3
Research Site
Kumamoto, Kumamoto, Japan
4
Research Site
Osaka, Osaka, Japan