NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Severe Sepsis, Septic Shock
Date of first enrollment	23/07/2010
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AZD9773 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : AZD9773 250 units/kg (1 infusion) + 50 units/kg (9 infusions) (Dose Cohort 1): A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days Generic name etc : AZD9773 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : AZD9773 500 units/kg (1 infusion) + 100 units/kg (9 infusions) (Dose Cohort 2): A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days control material(s) Generic name etc : a saline solution INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Intravenous infusion of a saline solution

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	- 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.
Exclude criteria	- Immunocompromising comorbidities or concomitant medications: 1. Advanced human immunodeficiency virus (HIV) infection (CD4 50/mm3 or less). 2. Haemopoietic or lymphoreticular malignancies not in remission. 3. Receiving radiation therapy or chemotherapy. 4. Any organ or bone marrow transplant within the past 24 weeks. 5. Absolute neutrophil count <500 per microL. 6. High dose steroids or other immunocompromising drugs. -Concomitant diseases: 1. Deep-seated fungal infection or active tuberculosis. 2. Server chronic liver disease associated with portal hypertension, cirrhosis, Choric ascites or Child-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 III or IV due to heart failure or any disorder. 8. Burns over >30% of body surface area in the past 5 days. -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 papain, chymopapain.