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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03996720
Eligibility Criteria:
Inclusion Criteria:
* The presence of at least two of the following four criteria, one of which must be abnormal temperature or leukocyte count:
* Coreb temperature of \>38.5°C or \<36°C.
* Tachycardia, defined as a mean heart rate \>2 SD above normal for age in the absence of external stimulus, chronic drugs, or painful stimuli; or otherwise unexplained persistent elevation over a 0.5- to 4-hr time period OR for children \<1 yr old: bradycardia, defined as a mean heart rate \<10th percentile for age in the absence of external vagal stimulus, β-blocker drugs, or congenital heart disease; or otherwise unexplained persistent depression over a 0.5-hr time period.
* Mean respiratory rate \>2 SD above normal for age or mechanical ventilation for an acute process not related to underlying neuromuscular disease or the receipt of general anesthesia.
* Leukocyte count elevated or depressed for age (not secondary to chemotherapy-induced leukopenia) or \>10% immature neutrophils
* A suspected or proven (by positive culture, tissue stain, or polymerase chain reaction test) infection caused by any pathogen OR a clinical syndrome associated with a high probability of infection. Evidence of infection includes positive findings on clinical exam, imaging, or laboratory tests
Exclusion Criteria:
* patients without informed consent
* discharge within 48 hours
Sex:
ALL
Minimum Age:
29 Days
Maximum Age:
18 Years
Study:
NCT03996720
Study Brief:
Protocol Section:
NCT03996720