Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01145560
Eligibility Criteria:
Inclusion Criteria:
* 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01145560
Study Brief:
Protocol Section:
NCT01145560