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:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT00430859
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 80 years (inclusive);
* proven or suspected infection;
* meeting 2 of 4 of the systemic inflammatory response syndrome (SIRS) criteria;
* septic shock or one or more acute organ failures in the preceding 12 hours;
* written informed consent obtained.
Exclusion Criteria:
* Pregnant or lactating women;
* known HIV seropositive patients;
* patients receiving immunosuppressive therapy or chronically using high doses of glucocorticosteroids (defined as \> 1 mg/kg/day) equivalent to prednisone 1 mg/kg/day;
* patients expected to have rapidly fatal disease within 24 h;
* known confirmed gram-positive sepsis;
* known confirmed fungal sepsis;
* chronic renal failure requiring haemodialysis or peritoneal dialysis;
* acute pancreatitis with no established source of infection;
* patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases;
* participation in another investigational study within 90 days prior to start of the study which might interfere with this study;
* previous administration of AP;
* known allergy for cow milk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00430859
Study Brief:
Protocol Section:
NCT00430859