Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231862
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-21
Brief Title:
Gene Expression Objective Definition of Early Sepsis In Children
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Gene Expression Objective Definition of Early Sepsis In Children
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEODESIC
Brief 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 Childrens will be equivalent to centralized assessment using SeptiCyteTM LAB
Approach Blood samples will be processed on site Seattle Childrens for SeptiCyte RAPID testing SeptiCyteTM RAPID is the result of the translation of the SeptiCyteTM LAB test to the cartridge-based Biocartis Idylla platform
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 Childrens will be equivalent to centralized assessment using SeptiCyteTM LAB
Approach Blood samples will be processed on site Seattle Childrens for SeptiCyte RAPID testing SeptiCyteTM RAPID is the result of the translation of the SeptiCyteTM LAB test to the cartridge-based Biocartis Idylla platform
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None