Near Patient Molecular Testing in Sepsis

Sepsis Clinical Trial

— NEPTUNE  

Official title:

Near Patient Molecular Testing in Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469048
• Other study ID #: NEPTUNE IXP-181
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2024
• Source: Immunexpress
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Rush University Medical Center	Chicago	Illinois
United States	Keck Hospital of University of Southern California (USC) and Los Angeles County and USC Medical Center	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Immunexpress	Grady Memorial Hospital, Rush University Medical Center, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Multi-parametric model to compare diagnostic accuracy between SeptiCyte RAPID alone or in combination with up to 15 other clinical parameters.	Time for enrollment, process samples, and collect data, an average of 1 year

External Links

•   Validation of SeptiCyte RAPID to Discriminate Sepsis from Non- Infectious Systemic Inflammation