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:
NCT04933760
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years old
2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
3. A 300µl blood sample originally collected in a K2 EDTA (hematology purple top) tube within 4 hours of the first recorded vital sign is available.
4. Sign or suspicion of infection, defined as meeting either of criterion A-1 and A-2 (based on temperature, WBC, heart rate, respiratory rate and/or culture order criteria):
Exclusion Criteria:
1. Patients in whom a palliative care or hospice course is expected during ED visit
2. Self-reported, documented or otherwise known to be actively enrolled on any experimental/investigational therapeutic medication prior to blood collection
3. Self-reported, documented, or known history of a hematologic malignancy (any leukemia, lymphoma, or myeloma), myelodysplastic syndrome, or myeloproliferative disorder
4. Self-reported, documented or otherwise known to receive a chemotherapeutic agent or other excluded medication in the past 3 months (Appendix C)
5. Self-reported, documented or otherwise known to have undergone a hematopoietic stem cell transplant or any solid organ transplant
6. Patients transferred to the Emergency Department from another acute care facility
7. Residents or patients of a hospital-based skilled nursing facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04933760
Study Brief:
Protocol Section:
NCT04933760