Near Patient Molecular Testing in Sepsis

NCT05469048 | Completed

• 1 other identifier: NEPTUNE IXP-181
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.

  Percentage of correctly identified patients with sepsis or non-infectious systemic inflammation using SeptiCyte RAPID compared to clinical assessments using routine clinical, laboratory, and other findings.

  Time for enrollment, process samples, and collect data, an average of 1 year

Secondary Outcomes (1)

• Comparison of diagnostic accuracy between SeptiCyte RAPID and up to 15 other clinical parameters in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.

  Time for enrollment, process samples, and collect data, an average of 1 year

Study Arms (1)

Critically ill patients sepsis suspected

Patients suspected of sepsis and admitted to ICU

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of sepsis, admitted to an Intensive Care Unit

You may qualify if:

• ≥18 years old on the date of ICU admission
• Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:
• Temperature \> 38°C or \< 36°C
• Heart Rate \> 90 beat/min
• Tachypnea \> 20/min or PaCO2 \< 32 mmHg
• WBC count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)
• Study sample collection within 24 hours of ICU admission order

You may not qualify if:

• Age less than 18 years old on the day of ICU admission
• No order to admit to ICU
• Not physically admitted to ICU
• Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
• Study sample collection \> 24 hours from ICU admission order
• No clinical cultures or serologic tests obtained when sepsis was suspected
• Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours
• Transfer from another ICU where subject was admitted for ≥ 24 hours.

Sponsors & Collaborators

• Immunexpress: lead
• Rush University Medical Center: collaborator
• Grady Memorial Hospital: collaborator
• University of Southern California: collaborator

Study Sites (3)

Keck Hospital of University of Southern California (USC) and Los Angeles County and USC Medical Center

Los Angeles, California, 90033, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Balk R, Esper AM, Martin GS, Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Greenberg JA, Yoder M, Patel G, Gilbert E, Parada JP, Afshar M, Kempker JA, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg PMC, Liebler J, Blodget E, Kumar S, Navalkar K, Yager TD, Sampson D, Kirk JT, Cermelli S, Davis RF, Brandon RB. Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation. J Clin Med. 2024 Feb 20;13(5):1194. doi: 10.3390/jcm13051194.

  PMID: 38592057 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected in PAXgene RNA tubes

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Roy Davis, MD, PhD, MHA

  Immunexpress

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 21, 2022
• Study Start: March 12, 2020
• Primary Completion: May 31, 2021
• Study Completion: October 31, 2022
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)