Gene Expression Objective Definition of Early Sepsis In Children

NCT06231862 | Completed

• 1 other identifier: STUDY00001733
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis; Non-Infectious Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• mRNA expression

  SeptiCyte (various) gene expression scores

  At PICU admission and 48 hours later

Study Arms (3)

Suspected/documented bacterial sepsis

Patients have evidence of an acute bacterial infection with organ dysfunction

Diagnostic Test: SeptiCyte (various)

Suspected/documented viral sepsis

Patients have evidence of an acute viral infection with organ dysfunction

Diagnostic Test: SeptiCyte (various)

Infection negative systemic inflammation (SIRS)

Patients have no active infection but exhibit SIRS

Diagnostic Test: SeptiCyte (various)

Interventions

SeptiCyte (various) DIAGNOSTIC_TEST

mRNA expression scores

Infection negative systemic inflammation (SIRS); Suspected/documented bacterial sepsis; Suspected/documented viral sepsis

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Critically ill children with systemic inflammatory response secondary to bacterial or viral sepsis or non-infectious SIRS

You may qualify if:

• INSI Cohort
• Admitted to the PICU
• New severe trauma OR
• New thermal burns OR
• Rheumatologic diagnoses OR
• Post-initiation (or circuit change) of extracorporeal life support OR
• Post anoxic-ischemic-reperfusion insults OR
• Infants undergoing cardiac surgery with cardiopulmonary bypass OR
• CAR-T cell therapy
• Parents speak English or Spanish AND
• Not previously enrolled in the GEODESIC investigation
• Pediatric Bacterial Sepsis Cohort
• Admitted to the PICU
• Parents speak English or Spanish AND
• Exhibit SIRS criteria including at least fever/hypothermia or leukocytosis/leukopenia or left shift on the leukocyte differential AND

You may not qualify if:

• Not expected to survive the PICU stay
• Child has 'ward of the state' status

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Immunexpress: collaborator

Study Sites (2)

Seattle Children's Hospital, Harborview Medical Center

Seattle, Washington, 98105, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paired blood samples for paired mRNA expression analysis, the first around the time of PICU admission and the second around 48 hours later

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jerry J Zimmerman, MD, PhD

  Seattle Children's Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: March 1, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

US (2)