NCT06231862

Gene Expression Objective Definition of Early Sepsis In Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

GEODESIC is a prospective descriptive cohort investigation that will examine the generalizability of the novel host gene expression biomarkers, SeptiCyteTM LAB, SeptiCyteTM VIRUS, SeptiCyteTM BACT, and SeptiCyteTM TRIAGE (collectively 18 genes or SeptiCyteTM LVBT) and SeptiCyteTM RAPID, for differentiating children with bacterial sepsis, versus severe viral illness, versus non-infectious related systemic inflammatory response syndrome.

Detailed description

Specific Aim 1. Validate the robustness of the SeptiCyteTM LVBT gene expression signatures for providing clear discrimination between critically ill children with bacterial sepsis versus severe viral illness versus infection-negative systemic inflammation (INSI) secondary to a variety of etiologies. Approach: We will expand our previous Genotypes And Phenotypes in Pediatric SIRS and Sepsis (GAPPSS) INSI cohort to children with recent trauma, thermal burns, anoxic-ischemic reperfusion events, exposure to cardiopulmonary bypass, extracorporeal life support, or dialytic therapy, CAR-T cell therapy, and various rheumatologic diagnoses. e we will recruit children with bacterial and viral infection who demonstrate a spectrum of illness severity and organ dysfunction. This specific aim will demonstrate the generalizability of SeptiCyteTM LVBT among critically children with life-threatening infectious disease or INSI. Specific Aim 2. Determine if SeptiCyteTM LVBT gene expression signatures trend towards resolution of previously induced or suppressed gene expression states as critical illness resolves. Approach: We will obtain paired blood samples for SeptiCyteTM LVBT gene expression, the first around the time of intensive care unit (ICU) admission (critically ill) and the second at ICU discharge approximately 48 hours later (transition to acute care). Resolution of critical illness will be quantified by serial daily measures of composite organ dysfunction. Specific Aim 3. Ascertain that performance of SeptiCyteTM RAPID utilizing a point of care device at Seattle Children's will be equivalent to centralized assessment using SeptiCyteTM LAB. Approach: Blood samples will be processed on site (Seattle Children's) for SeptiCyte RAPID testing. SeptiCyteTM RAPID is the result of the translation of the SeptiCyteTM LAB test to the cartridge-based Biocartis Idylla™ platform.

Conditions

• Sepsis
• Non-Infectious Systemic Inflammatory Response Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SeptiCyte (various)	mRNA expression scores

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

2 sites across 1 country: United States