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 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT03925857
Eligibility Criteria:
Inclusion Criteria:
* Suspected, presumed or documented infection from any source.
* Initiation of antibiotics.
* Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline.
* Adult male or female, age between 18 and 85.
* GCS of \>13 with verbal score of 5.
* Signed written informed consent by the patient.
Exclusion Criteria:
* Participation in an interventional investigational trial within 30 days prior to diagnosis of sepsis.
* Significant trauma requiring hospitalization within 30 days prior to diagnosis of sepsis.
* Surgical intervention or hospitalization within 45 days prior to diagnosis of sepsis.
* Pregnancy or breast-feeding female.
* Progressive or poorly-controlled malignancies or \< 6 month after active treatment for cancer (chemotherapy or irradiation).
* Terminally ill patients defined as patients that prior to the current hospitalization are expected to live \< 6 months (as assessed by the physician responsible for the patient).
* Known active acute or chronic viral infections, e.g. Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or other chronic infection.
* Known severe chronic respiratory health problems with severe pulmonary hypertension (≥40 mmHg) or respirator dependency.
* Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to: biopsy-proven cirrhosis; portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
* Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within six months prior to diagnosis of sepsis.
* Known immunocompromised state or medications known to be immunosuppressive.
* Organ allograft or previous history of stem cell transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03925857
Study Brief:
Protocol Section:
NCT03925857