SepsisGEODESICNCT06231862
Gene Expression Objective Definition of Early Sepsis In Children
An observational study of Sepsis and Non-Infectious Systemic Inflammatory Response Syndrome, run by Seattle Children's Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Sepsis, Non-Infectious Systemic Inflammatory Response Syndrome
- What is being tested?
- SeptiCyte (various)
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically ill children with systemic inflammatory response secondary to bacterial or viral sepsis or non-infectious SIRS
Who may be able to join
- 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
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- 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
- Strongly suspected or documented source of bacterial infection per primary care team
- Not previously enrolled in the GEODESIC investigation
- Pediatric Bacterial Sepsis Cohort
- Admitted to the PICU
- Parents speak English or Spanish AND
- Positive PCR or culture verifying a viral infection
- Not previously enrolled in the GEODESIC investigation
Who cannot join
- Not expected to survive the PICU stay
- Child has 'ward of the state' status
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Children's Hospital, Harborview Medical Center
Seattle, Washington, 98105
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Being tested
- SeptiCyte (various)
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeptiCyte (various)Diagnostic test
mRNA expression scores
| Study group | Role | What they receive |
|---|---|---|
| Suspected/documented bacterial sepsis | Patients have evidence of an acute bacterial infection with organ dysfunction Receives: Diagnostic Test: SeptiCyte (various) | |
| Suspected/documented viral sepsis | Patients have evidence of an acute viral infection with organ dysfunction Receives: Diagnostic Test: SeptiCyte (various) | |
| Infection negative systemic inflammation (SIRS) | Patients have no active infection but exhibit SIRS Receives: Diagnostic Test: SeptiCyte (various) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression
SeptiCyte (various) gene expression scores
Measured: At PICU admission and 48 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Mar 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Immunexpress
- Responsible party
- Sponsor
- Investigators
- Jerry J Zimmerman, MD, PhD, Principal investigator, Seattle Children's Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231862
- Sponsor's protocol ID
- STUDY00001733
- Acronym
- GEODESIC
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Objective Definition of Early Sepsis In Children
- ClinicalTrials.gov ID
- NCT06231862
- Acronym / sponsor ID
- GEODESIC / STUDY00001733
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Immunexpress
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected/documented bacterial sepsis | – | Diagnostic Test: SeptiCyte (various)Patients have evidence of an acute bacterial infection with organ dysfunction |
| Suspected/documented viral sepsis | – | Diagnostic Test: SeptiCyte (various)Patients have evidence of an acute viral infection with organ dysfunction |
| Infection negative systemic inflammation (SIRS) | – | Diagnostic Test: SeptiCyte (various)Patients have no active infection but exhibit SIRS |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically ill children with systemic inflammatory response secondary to bacterial or viral sepsis or non-infectious SIRS
Key inclusion criteria (22 listed)
- INSI Cohort
- Admitted to the PICU
- New severe trauma OR
- New thermal burns OR
- Rheumatologic diagnoses OR
Key exclusion criteria (2 listed)
- Not expected to survive the PICU stay
- Child has 'ward of the state' status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeptiCyte (various)mRNA expression scores | Diagnostic test | Infection negative systemic inflammation (SIRS), Suspected/documented bacterial sepsis, Suspected/documented viral sepsis |
Primary outcome
mRNA expression
Time frame: At PICU admission and 48 hours later
SeptiCyte (various) gene expression scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry J Zimmerman, MD, PhD principal investigator
Seattle Children's Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Non-Infectious Systemic Inflammatory Response Syndrome, run by Seattle Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA expression (time frame: At PICU admission and 48 hours later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.