Near Patient Molecular Testing in Sepsis

Completed

• Conditions: Sepsis; Systemic Inflammatory Response Syndrome

• Registration Number: NCT05469048
• Lead Sponsor: Immunexpress

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.

Detailed Description

The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.

Study Timeline

• Study Start: 2020-03-12
• Primary Completion: 2021-05-31
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Study Completion: 2022-10-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. ≥18 years old on the date of ICU admission

2. Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:

   1. Temperature > 38°C or < 36°C
   2. Heart Rate > 90 beat/min
   3. Tachypnea > 20/min or PaCO2 < 32 mmHg
   4. WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands)

3. Consent to study inclusion, either by patient or legal surrogate before study-related sample processing

4. Study sample collection within 24 hours of ICU admission order

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID 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	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.

Secondary Outcome Measures

Name	Time	Method
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	Multi-parametric model to compare diagnostic accuracy between SeptiCyte RAPID alone or in combination with up to 15 other clinical parameters.

Trial Locations

Locations (3)

Keck Hospital of University of Southern California (USC) and Los Angeles County and USC Medical Center; 🇺🇸 Los Angeles, California, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States